A Revolution in Hernia Repair:
ReliaTack™
ARTICULATING RELOADABLE
FIXATION DEVICE
SUPERIOR PERFORMANCE
FROM MANY ANGLES†,2
WITH NEW DEEP
PURCHASE TACKS
Deep Purchase Tack
Superior access £,1
Stronger fixation †,2
VALUE ANALYSIS BRIEF
£ In comparison to AbsorbaTack™ fixation device
† Compared to Absorbable and Permanent Fixation Devices Commercially Available, which include SecureStrap™*
device, SorbaFix™* device, OptiFix™* device, Capsure™* device, ProTack™ device and ReliaTack™ device with
Standard Purchase Tacks when the shaft is angled at 30°, 45°, 65° and 90° (bench testing)
§ Based on potential for eliminating contralateral ports and average savings when 31-50 tacks are needed
Standard Purchase Tack
Lower cost of care §,3
TABLE OF CONTENTS
3 Product Introduction
4 Features and Benefits
9 ReliaTack™ Technology Overview
10
Competitive Information
14
Ordering Information
15
Procedural Reimbursement Information
2
Cross Reference Charts
Hospital Inpatient Procedure Coding
18
Instructions For Use
20
510(k) Clearance
27
Surgeon Request Forms
COVIDIEN IS REVOLUTIONIZING
HERNIA REPAIR
Older, non-articulating fixation devices
present several challenges in laparoscopic
hernia repair.
Accessing the mesh can be difficult, fixation
strength can be less than ideal, and procedural
costs can increase dramatically when more than one
device is needed in a single procedure.1,2,3
ReliaTack™ Articulating Reloadable Fixation Device is
revolutionizing hernia repair.
First, articulate to 65 degrees to experience superior access
and stronger fixation.1,2 Next, use cost effective reloads
to lower the cost of care.§,3
Finally, experience the versatility of ReliaTack™ device.
Choose between standard or deep purchase tacks to meet
your unique patient and procedural needs.
§Based on potential for eliminating contralateral ports and average savings when 31-50 tacks are needed
3
Superior access £,1
Stronger fixation†,2
Lower cost of care §,3
SUPERIOR ACCESS£,1
For patients and surgeons, recurrence is one of the most concerning complications. Recurrence occurs mainly at the border
of the mesh, indicating insufficient overlap. That said, having consistent mesh overlap over the defect is essential.4
Mesh shift, which occurs in 48% of traditional lap ventral hernia repairs, can lead to insufficient mesh overlap. Furthermore,
92% of the time, mesh shift is the direct result of the mesh being pushed away from the operator during tacking.5
Reduce Mesh Shift with ReliaTack™ Fixation Device£,1
Mesh Shift with Non-Articulating Device
Mesh Shift with ReliaTack™ Fixation Device
Device Motion
The mesh is pushed away from the surgeon during tacking
10 Tacks
Device Motion
The mesh is kept in better position during tacking through articulation
Articulation reduces the potential for the mesh to be pushed away from the surgeon
during tacking. As a result, the mesh can remain in the desired position, with more
overlap over the defect.£,1,5
† Compared to Absorbable and Permanent Fixation Devices Commercially Available,
which include SecureStrap™* device, SorbaFix™* device, OptiFix™* device, Capsure™*
device, ProTack™ device and ReliaTack™ device with Standard Purchase Tacks when
the shaft is angled at 30°, 45°, 65° and 90° (bench testing)
4
£ In comparison to AbsorbaTack™ fixation device
§ Based on potential for eliminating contralateral ports and average savings when
31-50 tacks are needed
TO REDUCE RECURRENCE, EVERY CENTIMETER COUNTS4
Achieving consistent overlap of 5 cm or greater is important for patients with increased risk of recurrence, such as the morbidly
obese and those who have large defects.4 That said, reducing mesh shift caused by non-articulating fixation devices is integral to
reducing recurrence rates.4
Achieving consistent overlap
may decrease recurrences by
up to 14 percentage points4
Accurate Mesh Placement
Consistent 3 to 5 cm
overlap
0% to 7% recurrence in
laparoscopic approach4
Inaccurate Mesh Placement
Inconsistent overlap
9% to 14.3% recurrence in
laparoscopic approach4
5
STRONGER FIXATION†,2
Older, non-articulating fixation devices that use strap or nail style tacks can only be fired from a straight position. This makes
it challenging to find the right angle to tack the mesh.5 As a result, straps or nails are often fired at an angle to the mesh
which leads to lower fixation strength.2
Stronger fixation means confidence and peace of mind, knowing that your tacks are fixated securely through the mesh into
the abdominal wall.
ReliaTack™ with Deep Purchase Tacks demonstrates superior fixation strength compared to both
absorbable and permanent fixation devices when the shaft is angled at 30°, 45°, 65° and 90°†
Absorbable Fixation Devices:
Permanent Fixation Devices:
DPT is
DPT is
DPT is
STRONGER THAN
OptiFix™* device†
STRONGER THAN
SecureStrap™* device†
STRONGER THAN
CapSure™* device†
3.9x
3.3x
1.7x
DPT is
DPT is
DPT is
STRONGER THAN
SorbaFix™* device†
STRONGER THAN
ReliaTack™ device
with standard purchase tacks†
STRONGER THAN
ProTack™ device†
1.9x
1.5x
1.6x
DEEP PURCHASE TACK FIXATION STRENGTH
Pounds of Force
6
5
4
3
2
1
0
30°
45°
60°
45
90°
Tack Deployment Angle
¢ ReliaTack™ Device w/ Deep Purchase Tacks
¢ SorbaFix™* Device
™
Tack
Deployment
¢ ReliaTack
Device w/Angle
Standard Purchase Tacks
¢ CapSure™* Device
¢ SecureStrap™* Device
† Compared to the average fixation strength when the shaft is angled at 30°, 45°, 65° and 90° (bench testing)
6
¢ ProTack™ Device
¢ OptiFix™* Device
PERPENDICULAR TACK DEPLOYMENT
Secure tack fixation is critical to performing a durable and successful hernia repair. Furthermore, tacks have the most
strength and security when they are fired perpendicular to the mesh and tissue.2
65 degrees of articulation allows ReliaTack™ device to deliver perpendicular tack fixation,
consistent tack purchase and superior fixation strength.†,2
SecureStrap
™*
tack
SorbaFix
™*
tack
OptiFix
™*
tack
ReliaTack™ deep
purchase tack
ReliaTack™ standard
purchase tack
A COMFORTABLE ANGLE ON HERNIA REPAIR
Because non-articulating devices can only fire from a straight position, surgeons often choose between adding additional
ports or firing the device from an uncomfortable position.
Articulation can eliminate the need for contralateral ports and allows the surgeon to fire the device from a more
comfortable position. As a result, surgeons can fixate the entire mesh from one port, one side of the patient, and one
comfortable position.¥,1
Natural, upright body position when using
ReliaTack™ fixation device
Fatiguing body position when using
non-articulating fixation device
† Compared to Absorbable and Permanent Fixation Devices Commercially Available, which include SecureStrap™* device, SorbaFix™* device, OptiFix™* device, Capsure™*
device, ProTack™ device and ReliaTack™ device with Standard Purchase Tacks when the shaft is angled at 30°, 45°, 65° and 90° (bench testing)
¥ In comparison to non-articulating fixation devices
7
LOWER COST OF CARE§,3
Non-articulating devices have a limited number of tacks. When more than 25 tacks are needed in a single procedure, the
surgical team will open a completely new device, dramatically increasing the cost of the procedure.∑,3
ReliaTack™ fixation device doesn’t just articulate; it’s also reloadable. Cost effective, interchangeable reloads lower the cost
of care by eliminating the need for multiple fixation devices per case. On average, ReliaTack™ fixation device can provide
$361 in savings per case over SecureStrap™* and Sorbafix™*.¤, 3
Additionally, articulation can save up to $100 per case by potentially eliminating contralateral ports.7 As a result,
ReliaTack™ device provides $461 in average savings per case.¤,3,7
May save up to $461 per case compared to SecureStrap™* device and SorbaFix™* device¤
,¶
ReliaTack™ fixation device
with standard purchase tacks
ReliaTack™ fixation device
with deep purchase tacks
SecureStrap™* fixation device
SorbaFix™* fixation device
£ In comparison to AbsorbaTack™ fixation device
§ Based on potential for eliminating contralateral ports and
average savings when 31-50 tacks are needed
∑ When using Ethicon SecureStrap™*
8
¤ Average of greatest estimated per-case savings over SecureStrap™* and
Sorbafix™* when 31-50 tacks are needed
‡ When 30-60 tacks are needed
¶ Articulation may save up to $100 per case by potentially eliminating
contralateral ports
TECHNOLOGY OVERVIEW
ReliaTack™ articulating reloadable fixation device is a truly amazing breakthrough in hernia repair. Its articulating
technology, interchangeable reloads, and screw-like tack designs are one of a kind.
65˚
ReliaTack™ Device Handle
Unique
Screw-Like
Standard
Purchase
Tack
5.1 mm
ReliaTack™ Interchangeable
5- and 10- Standard
Purchase Tack Reloads
Unique
Screw-Like
Deep
Purchase
Tack
7.0 mm
ReliaTack™ Interchangeable
5- and 8-Deep Purchase
Tack Reloads
9
Competitive Information
CROSS-REFERENCE
Interchangeable 5, 8, and 10 tack reloads can eliminate the need for multiple fixation devices in a single procedure.‡ In
many cases, the surgical team can open a reload instead of opening an entirely new device. This helps to lower cost and
reduce inventory.3
Covidien
BARD
Ethicon
ReliaTack™ Articulating
Reloadable Fixation Device with
Standard Purchase Tacks
SorbaFix™* Device
SecureStrap™* Device
Code
Description
Quantity
RELTACK3X10
ReliaTack™ Articulating
Reloadable Fixation Device
with 30 absorbable tacks
6/box
RELTACK10R
ReliaTack™ Articulating
Reloadable Fixation Device
Reload with 10 Standard
Purchase absorbable tacks
6/box
RELTACK5R
ReliaTack™ Articulating
Reloadable Fixation Device
Reload with 5 Standard
Purchase absorbable tacks
6/box
Code
0113115
SorbaFix™*
Laparoscopic
Fixation Device
with 15 Tacks
5/box
0113116
SorbaFix™*
Laparoscopic
Fixation Device
with 30 Tacks
5/box
ReliaTack™ Articulating
Reloadable Fixation Device
with Deep Purchase Tacks
‡
10
RELTACK4xDPT
ReliaTack™ Articulating
Reloadable Fixation Device
with 3x 8 Deep Purchase
Tack reloads and 1x 5 Deep
Purchase Tack reload
6/box
RELTACK5RDPT
ReliaTack™ Articulating
Reloadable Fixation Device
Reload with 5 Deep Purchase
absorbable tacks
6/box
RELTACK8RDPT
ReliaTack™ Articulating
Reloadable Fixation Device
Reload with 8 Deep Purchase
absorbable tacks
6/box
When 30 - 60 tacks are needed
Description Quantity
OptiFix™* Device
0113126
OptiFix™*
5/box
Absorbable
Fixation System
with 30
absorbable
tacks
0113127
OptiFix™*
5/box
Absorbable
Fixation System
with 15
absorbable
tacks
Code
Strap25
Description Quantity
SecureStrap™*
Absorbable
Strap Fixation
Device with 25
Straps
6/box
SIDE-BY-SIDE COMPARISON
ReliaTack™ fixation device provides several powerful advantages over non-articulating devices. 65 degrees of
articulation and interchangeable 5-, 8-, and 10-tack reloads make older, non-articulating fixation devices a thing
of the past.
65 degrees of articulation delivers optimal access to mesh fixation sites, making it possible to achieve
perpendicular tack deployment and minimize mesh shift.1
DEGREES OF ARTICULATION
ReliaTack™ Fixation Device
65˚
BARD SorbaFix™* Fixation Device
Ethicon SecureStrap™* Fixation Device
0˚
0˚
BARD OptiFix™* Fixation Device
0˚
11
TACK DESIGN
Our unique, screw-like tacks provide more fixation strength than nail or prong-style tacks.2
ReliaTack™ Device with Standard Purchase Tacks
Fixation
Threads
4.1 mm
Purchase
Depth
4.8 mm
ReliaTack™ Device with Deep Purchase Tacks
Fixation
Threads
12
SecureStrap™* Fixation Device
6.0 mm
Purchase
Depth
OptiFix™* Fixation Device
4.24 mm
Purchase
Depth
Purchase
Depth
TACKS PER DEVICE
Through interchangeable reloads, ReliaTack™ device can be fired up to 60 times, which is 2x more than
other devices.6
ReliaTack™ Fixation Device
60
BARD SorbaFix™*
30
BARD OptiFix™*
30
Ethicon SecureStrap™*
25
13
Ordering Information
RELIATACK™ DEVICE FAMILY
ReliaTack™ Device with Standard Purchase Tacks
RELTACK3X10
RELTACK10R
1x handle with
3x 10-tack standard purchase reloads
10-tack standard purchase reload
5.1 mm
RELTACK5R
5-tack standard purchase reload
Standard Purchase Tack
ReliaTack™ Device with Deep Purchase Tacks
7.0 mm
RELTACK4XDPT
RELTACK8RDPT
1x handle with
3x 8-tack deep purchase reloads and
1x 5-tack deep purchase reload
8-tack deep purchase reload
RELTACK5RDPT
5-tack deep purchase reload
Deep Purchase Tack
ReliaTack™ device family provides you with options for each unique patient and procedure.
14
Reimbursement Information
PHYSICIAN
CPT™*
HCPCS
CODE
+495681
49652
Procedure Description
Implantation of mesh or other
prosthesis for open incisional or
ventral hernia repair or mesh
for closure of debridement for
necrotizing soft tissue infection (List
separately in addition to code for the
incisional or ventral hernia repair)
Laparoscopy, surgical, repair, ventral,
umbilical, spigelian or epigastric
hernia (includes mesh insertion,
when performed); reducible
*MPFS
(CF=$35.8228)
Fac/Non-Fac
AMBULATORY
SURGICAL CENTER
HOSPITAL OUPATIENT
APC
Classification
APC
Descriptor
$278.02
NA
NA
$772.09
5361
Level III
Laparoscopy
**APC
Rate
Packaged
into
Payment
for Other
Services
***ASC
Packaged
Service/Item
$4,001.15
$2,010.99
$4,001.15
$2,010.99
49653
Laparoscopy, surgical, repair, ventral,
umbilical, spigelian or epigastric
hernia (includes mesh insertion,
when performed); incarcerated or
strangulated
$963.05
5361
49654
Laparoscopy, surgical, repair, incisional
hernia (includes mesh insertion,
$876.71
when performed); reducible
5362
Level III
Laparoscopy
$6,860.91
$3,277.62
5362
Level III
Laparoscopy
$6,860.91
$3,277.62
5362
Level III
Laparoscopy
$6,860.91
$3,277.62
49655
49656
Laparoscopy, surgical, repair, incisional
hernia (includes mesh insertion,
$1,070.54
when performed); incarcerated or
strangulated
Laparoscopy, surgical, repair, recurrent
incisional hernia (includes mesh
$954.10
insertion, when performed); reducible
Level III
Laparoscopy
ICD-10-PCS Hospital Procedure Codes
ICD-10 went into effect on October 1, 2015. ICD-10-PCS procedure codes are used by hospitals to report surgeries
and procedures performed in the inpatient setting.
All ICD-10-PCS codes have seven digits, each digit representing a specific character associated with procedures.
Code assignment in ICD-10-PCS is a process of “constructing” the code by selecting values from a code table for
each of the seven standard characters. The first three characters identify the code table that is used to complete
the remaining four characters.
15
Reimbursement Information
Examples
SECTION
BODY SYSTEM
OPERATION
0 Medical And Surgical
W Anatomical Regions, General
U Supplement: Putting in or on biological or synthetic material that physically reinforces and/or augments the
function of a portion of a body part
BODY PART
APPROACH
0 Head
2 Face
4 Upper Jaw
5 Lower Jaw
6 Neck
8 Chest Wall
C Mediastinum
F Abdominal Wall
K Upper Back
L Lower Back
M Perineum, Male
N Perineum, Female
0 Open
4 Percutaneous Endoscopic
DEVICE
QUALIFIER
7 Autologous Tissue Substitute
J Synthetic Substitute
K Nonautologous Tissue Substitute
Z No Qualifier
• Laparoscopic repair of incisional hernia with Permacol mesh
0WUF4KZ Supplement abdominal wall with nonautologous tissue substitute, percutaneous endoscopic
approach
• Laparoscopic repair of incisional hernia with polyester mesh
0WUF4JZ Supplement abdominal wall with synthetic substitute, percutaneous endoscopic approach
• Laparoscopic repair of non-incisional hernia of anterior abdominal wall with polyester mesh
0WUF4JZ Supplement abdominal wall with synthetic substitute, percutaneous endoscopic approach
• Open closure of penetrating stab wound of the abdomen with synthetic mesh
0WUF0JZ Supplement abdominal wall with synthetic substitute, open approach
HOSPITAL DRG Payment Rates
MS-DRG
MS-DRG TITLE
FY 2016
Relative
Weight15
FY 2016 Medicare
Average18
Repair of Diaphragmatic Hernia (Hiatal Hernia, Paraesophageal Hernia)
326
Stomach, Esophageal and Duodenal Procedures W MCC
5.4452
$32,160
327
Stomach, Esophageal and Duodenal Procedures W CC
2.6399
$15,592
328
Stomach, Esophageal and Duodenal Procedures WO CC/MCC
1.5154
$8,950
Hernia Repair - Inguinal, Femoral
350
Inguinal and Femoral Hernia Procedures W MCC
2.4982
$14,755
351
Inguinal and Femoral Hernia Procedures W CC
1.4110
$8,334
352
Inguinal and Femoral Hernia Procedures WO CC/MCC
0.9764
$5,767
16
Reimbursement Information
MS-DRG
MS-DRG TITLE
FY 2016
Relative
Weight15
FY 2016 Medicare
Average18
Hernia Repair - Other (Epigastric, Incisional/Ventral, Lumbar, Parastomal, Spigelian, Umbilical)
353
Hernia Procedures Except Inguinal and Femoral W MCC
2.9142
$17,212
354
Hernia Procedures Except Inguinal and Femoral W CC
1.6640
$9,828
Hernia Procedures Except Inguinal and Femoral WO CC/MCC
1.2366
$7,304
582
Mastectomy for Malignancy W CC/MCC
1.3370
$7,896
583
Mastectomy for Malignancy WO CC/MCC
1.1856
$7,002
584
Breast Biopsy, Local Excision and Other Breast Procedures W CC/MCC
1.6794
$9,919
585
Breast Biopsy, Local Excision and Other Breast Procedures WO CC/MCC
1.5184
$8,968
355
TRAM Flap
20
Abdominal Wall Repair for Trauma
21
907
Other OR Procedures for Injuries W MCC
3.8073
$22,486
908
Other OR Procedures for Injuries W CC
1.9904
$11,756
909
Other OR Procedures for Injuries WO CC/MCC
1.2992
$7,673
957
Other OR Procedures for Multiple Significant Trauma W MCC
6.5504
$38,688
958
Other OR Procedures for Multiple Significant Trauma W CC
3.8565
$22,777
959
Other OR Procedures for Multiple Significant Trauma W CC/ MCC
2.1705
$12,819
Estimates are based on 2016 data. Healthcare providers are responsible for appropriate coding and obtaining reimbursement information. Covidien cannot be
held accountable for incorrect information.
‡ CMS 2016 Alpha Numeric HCPCS File Updated 11/5/2015 https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCSItems/2016-Alpha-Numeric-HCPCS-File.html
* PFS Relative Value Files, RVU132(11 5 15) effective January 2016 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/
PFS-Federal-Regulation-Notices-Items/CMS-1631-FC.html?DLPage=1&DLEntries=10&DLSort=2&DLSortDir=descending
** CMS-1333-CN HOPPS Addendum A and B, effective January 1, 2016 HYPERLINK “https://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/HospitalOutpa%1ftientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1633-FC.html” https://www.cms.gov/
Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpa¬tientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1633-FC.html?
DLPage=1&DLEntries=10&DLSort=2&DLSortDir=descending
***CMS 1633 ASC Addendum AA, BB, DD1, DD2 and EE, effective January 1, 2016 HYPERLINK “https://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/AS%1fCPayment/ASC-Regulations-and-Notices-Items/CMS-1633-FC.html” https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/
AS-CPayment/ASC-Regulations-and-Notices-Items/CMS-1633-FC.html
Centers for Medicare & Medicaid Services. Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term
Care Hospital Prospective Payment System Changes and FY2016 Rates Final Rule, 80 Fed. Reg. 49326-49843. http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/
pdf/2015-19049.pdf. Published August 17, 2015 .
17
INSTRUCTIONS FOR USE
ReliaTack™
Articulating Reloadable Fixation Device with Standard and Deep
Purchase Absorbable Tacks
PT00031815
A
ReliaTack™ B
C
D
E
Articulating Reloadable Fixation Device with Standard and Deep
G Tacks
J
H
K
I
Purchase Absorbable
F
L
PT00031815
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
IMPORTANT!
This booklet is designed to assist inA
using this product. It is not a reference to surgical techniques.
B C
E this device may lead to its failure and subsequent patient
This device was designed, tested and manufactured
for single patient D
use only. Reusing or reprocessing
injury. Reprocessing and/or resterilizing this device may create the risk of contamination and patient infection. Do not reuse, reprocess or resterilize this device.
DESCRIPTION
K of prosthetic material, such as mesh, to soft tissue. The tack
H single patient
I use Jdevice for fixation
The ReliaTack™ articulating reloadable fixationG
device is a sterile,
Fpolyester copolymer derived from lactic and glycolic acid and is dyed with D&CLViolet No. 2. The device is offered as a
is constructed of an absorbable synthetic
stand-alone reloadable handle prepackaged with a set of single-use reloads, (either 3-standard purchase tack reloads or 4-deep purchase tack reloads); all reloads
are designed to be used with the handle provided.
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
The ReliaTack™ articulating reloadable fixation device can accommodate:
IMPORTANT!
-5 and 10 tack standard purchase tack reloads with 5.1 mm long absorbable poly (glycolide-co-L-lactide) (PGLA) tacks
This booklet is designed to assist in using this product. It is not a reference to surgical techniques.
-5 and 8 tack deep purchase tack reloads with 7.0 mm long absorbable PGLA tacks
This device was designed, tested and manufactured for single patient use only. Reusing or reprocessing this device may lead to its failure and subsequent patient
Tack
Chartresterilizing this device may create the risk of contamination and patient infection. Do not reuse, reprocess or resterilize this device.
injury.Specification
Reprocessing and/or
Deep Purchase Tack
DESCRIPTION
Standard Purchase Tack
The ReliaTack™ articulating reloadable fixation device is a sterile, single patient use device for fixation of prosthetic material, such as mesh, to soft tissue. The tack
Tack
Specification
Chart
is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2. The device is offered as a
stand-alone reloadable handle prepackaged with a set of single-use reloads, (either 3-standard purchase tack reloads or 4-deep purchase tack reloads); all reloads
are designed to be used with the handle provided.
Tacks Per
Reload fixation device can accommodate: 5 or 10
5 or 8
The ReliaTack™ articulating
reloadable
Reload
Marking
Black Band
-5 and 10 tack standard
purchase
tack reloads with 5.1 mm long absorbable-------poly (glycolide-co-L-lactide) (PGLA) tacks
Total Tacktack
Length
5.1tacks
mm
7.0 mm
-5 and 8 tack deep purchase
reloads with 7.0 mm long absorbable PGLA
TackChart
Purchase Depth
4.1 mm
6.0 mm
Tack Specification
Minimum Tissue Thickness*
4.2 mm
6.1 mm
Deep Purchase Tack
Standard Purchase Tack
* Physicians should
that tissueChart
thickness sufficiently exceeds tack length, based on their own clinical evaluation of the tissue.
Tackconfirm
Specification
The device can be reloaded and fired for a total of 60 tacks in a single procedure. The sterile package contains a reload counter/holder and storage card.
The surgical staff should use the reload counter/holder and storage card to collect and account for all reloads that enter the sterile field during a procedure.
5 or 10
5 or 8
INDICATIONS Tacks Per Reload
Marking
-------Black Band such as hernia repair.
The device is intendedReload
for fixation
of prosthetic material to soft tissue in various
minimally invasive and open surgical procedures
Total Tack Length
5.1 mm
7.0 mm
CONTRAINDICATIONS
1. The device is not Tack
intended
for use
when prosthetic material fixation is contraindicated.
Purchase
Depth
4.1 mm
6.0 mm
2. Do not use theMinimum
ReliaTack™
fixation
device on tissue(s) which cannot be inspected
Tissue
Thickness*
4.2 mm visually for hemostasis.
6.1 mm
3. This device should not be used in tissues that have a direct anatomic relationship to major vascular structures. This would include the deployment of tacks in the
the vicinity
of the
aortasufficiently
or inferiorexceeds
vena cava
diaphragmatic
*diaphragm
Physiciansinshould
confirm
thatpericardium,
tissue thickness
tackduring
length,
based on theirhernia
own repair.
clinical evaluation of the tissue.
4. Dodevice
not use
necrotic
tissue.
The
canonbeischemic
reloadedorand
fired for
a total of 60 tacks in a single procedure. The sterile package contains a reload counter/holder and storage card.
ACTIONS
The
surgical staff should use the reload counter/holder and storage card to collect and account for all reloads that enter the sterile field during a procedure.
The
tack is made of the common copolymer PGLA. This copolymer degrades and is absorbed by hydrolysis to glycolic acid and lactic acid which are then
INDICATIONS
metabolized
the body.
The
device is by
intended
for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair.
The
absorption profile of PGLA in the first two weeks after initial implantation is minimal with a significant absorption rate seen in the period from 3 months to 5
CONTRAINDICATIONS
months.
Following
significant
the polymer
absorption
completed prior to one year.
1.
The device
is not this
intended
for usebreakdown
when prosthetic
material
fixation isis essentially
contraindicated.
WARNINGS
AND
PRECAUTIONS
2.
Do not use the
ReliaTack™
fixation device on tissue(s) which cannot be inspected visually for hemostasis.
1. Procedures for endoscopic and open prosthetic fixation surgery should be performed only by qualified physicians familiar with these techniques.
3. This device should not be used in tissues that have a direct anatomic relationship to major vascular structures. This would include the deployment of tacks in the
2. When instruments
and ofaccessories
from different
are employed
together in a hernia
procedure,
diaphragm
in the vicinity
the pericardium,
aorta ormanufacturers
inferior vena cava
during diaphragmatic
repair.verify compatibility prior to initiation of the procedure
and ensure that any electrical insulation or grounding is not compromised.
4. Do not use on ischemic or necrotic tissue.
3. Prior to tack deployment ensure that the distal tip of the device is as close to perpendicular as possible to the targeted tissue to facilitate appropriate insertion
ACTIONS
of the tack. After tack deployment confirm full insertion of the tack into the mesh and/or tissue, the shoulder of the tack should be flush with the surface of the
The tack is made of the common copolymer PGLA. This copolymer degrades and is absorbed by hydrolysis to glycolic acid and lactic acid which are then
material being fixated.
metabolized by the body.
4. The articulating elbow must be completely visible (beyond the distal end of the trocar sleeve) and not in direct contact with viscera or the abdominal wall while
The absorption profile of PGLA in the first two weeks after initial implantation is minimal with a significant absorption rate seen in the period from 3 months to 5
articulating or straightening the device within the body cavity to avoid potential tissue entrapment.
months. Following this significant breakdown the polymer absorption is essentially completed prior to one year.
5. In the unlikely case of joint failure, the device can only be removed through a 12 mm access port if it was used for the instrument port. Otherwise the entire 5 mm
WARNINGS AND PRECAUTIONS
port must be removed together with the device through the incision.
1. Procedures for endoscopic and open prosthetic fixation surgery should be performed only by qualified physicians familiar with these techniques.
6. Use caution when the articulating elbow of the device may come into direct contact with viscera to avoid potential tissue trauma.
2. When instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility prior to initiation of the procedure
7.
minimum
of tissue
over underlying
bone,is not
vessels,
or viscera is needed for full engagement of the tack. Failure to appropriately assess the length of
andA ensure
thatthickness
any electrical
insulation
or grounding
compromised.
tack versus tissue thickness may result in inadvertent damage to surrounding structures. Please confirm that the appropriate tack length is chosen before firing.
3. Prior to tack deployment ensure that the distal tip of the device is as close to perpendicular as possible to the targeted tissue to facilitate appropriate insertion
The total distance from the surface of the tissue (including the material to be fixated) to the underlying bone, vessels, or viscera should be carefully evaluated prior
of the tack. After tack deployment confirm full insertion of the tack into the mesh and/or tissue, the shoulder of the tack should be flush with the surface of the
to application of the device. Please refer to the tack specification chart for specific minimum tissue thickness requirements.
material being fixated.
8. Tacking into tissues near the heart, such as through diaphragm or in the chest cavity, could result in critical injury to cardiac tissues or other major vascular
4. The articulating elbow must be completely visible (beyond the distal end of the trocar sleeve) and not in direct contact with viscera or the abdominal wall while
structures.
articulating or straightening the device within the body cavity to avoid potential tissue entrapment.
9. Thicker, completely microporous prosthetic material (over 1.0 mm) may compromise full engagement of the tack. Material thickness should be carefully
5. In the unlikely case of joint failure, the device can only be removed through a 12 mm access port if it was used for the instrument port. Otherwise the entire 5 mm
evaluated prior to application.
port must be removed together with the device through the incision.
10. Appropriate force should be applied to the handle of the device when placing tacks. Excessive force may result in damage to the tissue, device and/or the
6. Use caution when the articulating elbow of the device may come into direct contact with viscera to avoid potential tissue trauma.
material being fixated.
7. A minimum thickness of tissue over underlying bone, vessels, or viscera is needed for full engagement of the tack. Failure to appropriately assess the length of
11. The device should not be used in procedures where soft tissue fixation would not normally be used.
tack versus tissue thickness may result in inadvertent damage to surrounding structures. Please confirm that the appropriate tack length is chosen before firing.
12.
should
used where
fixationtheismaterial
desired. to be fixated) to the underlying bone, vessels, or viscera should be carefully evaluated prior
TheThe
totaldevice
distance
fromnot
thebesurface
of the permanent
tissue (including
18
4. The articulating elbow must be completely visible (beyond the distal end of the trocar sleeve) and not in direct contact with viscera or the abdominal wall while
articulating or straightening the device within the body cavity to avoid potential tissue entrapment.
5. In the unlikely case of joint failure, the device can only be removed through a 12 mm access port if it was used for the instrument port. Otherwise the entire 5 mm
port must be removed together with the device through the incision.
6. Use caution when the articulating elbow of the device may come into direct contact with viscera to avoid potential tissue trauma.
7. A minimum thickness of tissue over underlying bone, vessels, or viscera is needed for full engagement of the tack. Failure to appropriately assess the length of
tack versus tissue thickness may result in inadvertent damage to surrounding structures. Please confirm that the appropriate tack length is chosen before firing.
The total distance from the surface of the tissue (including the material to be fixated) to the underlying bone, vessels, or viscera should be carefully evaluated prior
to application of the device. Please refer to the tack specification chart for specific minimum tissue thickness requirements.
8. Tacking into tissues near the heart, such as through diaphragm or in the chest cavity, could result in critical injury to cardiac tissues or other major vascular
structures.
9. Thicker, completely microporous prosthetic material (over 1.0 mm) may compromise full engagement of the tack. Material thickness should be carefully
evaluated prior to application.
10.
force
should be applied
to the handle
of the and
device
when
placingafter
tacks.they
Excessive
forceused
mayduring
result inthedamage
to the
the
17. Appropriate
Use the reload
counter/holder
and storage
card to count
store
all reloads
have been
procedure.
At tissue,
the enddevice
of theand/or
procedure
materialthat
being
fixated.that are in the sterile field have been inserted into the counter/holder and storage card. DISCARD the counter/holder and storage card and
ensure
all reloads
11.reloads
The device
all
aftershould
use. not be used in procedures where soft tissue fixation would not normally be used.
12. The instrument
device should
be used
permanent
is desired.for a SINGLE procedure only. DO NOT SAVE UNUSED RELOADS FOR LATER USE. DO NOT
18.
andnotreloads
arewhere
provided
STERILE fixation
and are intended
RESTERILIZE.
Reprocessing
or resterilization
compromise
thebleeding
device integrity
and could lead
patient injury,ororother
illness.
Reuse, even
after resterilization, may
13. Always inspect
the fixation
site to ensuremay
hemostasis.
Minor
may be controlled
withtoelectrocautery
appropriate
methods.
create a risk of contamination and lead to patient infection or the transmission of infectious diseases.
14. Do not fire the instrument prior to removing the shipping wedge.
19. Dispose of the used fixation device, the counter/holder and storage card, and all reloads in the sterile field in accordance with the end-user’s medical and
15. Do not squeeze the handle while reloading the device.
biological waste disposal requirements.
16. Ensure that the device is in fire mode and the lock switch button is in the forward position upon inserting and removing the device from the trocar. Retraction
ADVERSE REACTIONS
of the lock switch button in reload mode will cause the reload to be released and potentially fall into the body cavity.
Adverse reactions and potential complications associated with fixation devices such as ReliaTack™ fixation device may include but are not limited to seroma,
17.
Use the reload counter/holder
and storage
to count
and store
all reloads
after theyreaction,
have been
usedadhesions,
during the nerve
procedure.
At the end
of theperforation
procedureof
bleeding/hematoma,
recurrence, chronic
pain, card
infection,
allergic
reactions,
inflammatory
visceral
entrapment,
and/or
ensure
that allpericardium,
reloads thatbladder,
are in theureter,
sterilevascular
field have
been inserted
the counter/holder
and storage
DISCARD
the counter/holder
and storage
small bowel,
structures,
or otherinto
visceral
structures, if tacks
migrate card.
and/or
are deployed
into inappropriate
tissues.card and
all reloads after use.
SCHEMATIC VIEW
18. The instrument and reloads are provided STERILE and are intended for a SINGLE procedure only. DO NOT SAVE UNUSED RELOADS FOR LATER USE. DO NOT
A) TOGGLE BUTTON
RESTERILIZE.
Reprocessing or resterilization may compromise the device integrity and could lead to patient injury, or illness. Reuse, even after resterilization, may
B) LOCKa risk
SWITCH
create
of contamination and lead to patient infection or the transmission of infectious diseases.
C) ARTICULATION
19.
Dispose of theKNOB
used fixation device, the counter/holder and storage card, and all reloads in the sterile field in accordance with the end-user’s medical and
biological
D) SHAFT waste disposal requirements.
ADVERSE
REACTIONS
E)
PIN
Adverse reactions and potential complications associated with fixation devices such as ReliaTack™ fixation device may include but are not limited to seroma,
F) TRIGGER
bleeding/hematoma, recurrence, chronic pain, infection, allergic reactions, inflammatory reaction, visceral adhesions, nerve entrapment, and/or perforation of
G)
5-TACK
STANDARD
PURCHASE
small
bowel,
pericardium,
bladder,RELOAD
ureter, vascular structures, or other visceral structures, if tacks migrate and/or are deployed into inappropriate tissues.
H) 10-TACK STANDARD PURCHASE RELOAD
SCHEMATIC VIEW
I) SHIPPING WEDGE
A) TOGGLE BUTTON
J) 5-TACK DEEP PURCHASE RELOAD
B) LOCK SWITCH
K) 8-TACK DEEP PURCHASE RELOAD
C) ARTICULATION KNOB
L) RELOAD COUNTER / HOLDER CARD AND STORAGE CARD
D) SHAFT
LOADING
E) PIN
CAUTION: Do not attempt to remove the shipping wedge until the RELOAD is locked and loaded onto the instrument.
F) TRIGGER
1. Ensure the device is in reload mode, red toggle button exposed, and the device is in the straight (unarticulated) position.
G) 5-TACK STANDARD PURCHASE RELOAD
2. To load the ReliaTack™ device select the appropriate reload, then pull and hold the blue lock switch button, located on top of the instrument, in the back position.
H) 10-TACK STANDARD PURCHASE RELOAD
Insert the pin located at the distal end of the shaft into the reload. Ensure that the arrow on the shaft is aligned with the arrow on the reload. Push the reload onto
I) SHIPPING
the
distal endWEDGE
of the shaft until the two arrows meet. Release the lock switch button allowing it to return to the forward position.
J) 5-TACK
DEEPonPURCHASE
3.
Gently pull
the reload RELOAD
to confirm that the device is properly loaded.
K) Remove
8-TACK DEEP
PURCHASE
RELOAD
4.
the shipping
wedge
once the reload is properly locked and loaded.
L)
RELOAD COUNTER / HOLDER CARD AND STORAGE CARD
UNLOADING
1.
Push the left side of the toggle button to expose the red portion of the button and ensure that the device is in the straight (unarticulated) position.
LOADING
2.
Pull and hold
the blue
lock switch
button, located
on top ofwedge
the instrument,
in the
back position.
CAUTION:
Do not
attempt
to remove
the shipping
until the
RELOAD
is locked and loaded onto the instrument.
3.
thethe
reload
off isofinthereload
shaftmode,
of the red
device.
1. Pull
Ensure
device
toggle button exposed, and the device is in the straight (unarticulated) position.
4.
Insert
reload into
theselect
reloadthe
counter/holder
and storage
card.and hold the blue lock switch button, located on top of the instrument, in the back position.
2. To
loadthe
theused
ReliaTack™
device
appropriate reload,
then pull
Insert
the pin located
at the
INSTRUCTIONS
FOR
USEdistal end of the shaft into the reload. Ensure that the arrow on the shaft is aligned with the arrow on the reload. Push the reload onto
the distal
theinserted
shaft until
the two
button
to return
to the
forward
position.invasive procedures. Do not
The
deviceend
mayofbe
through
a 5 arrows
mm or meet.
larger Release
(with thetheuselockof switch
a converter
or allowing
universal itseal)
cannula
for use
in minimally
attempt
insert
or remove
instrument
fromdevice
the trocar
sleeveloaded.
if the instrument is in the articulated position. The device may also be used in open procedures.
3. Gentlytopull
on the
reload totheconfirm
that the
is properly
1.
devicewedge
is in fireonce
mode,
buttonlocked
exposed.
4. Ensure
Removethat
thethe
shipping
thegreen
reloadtoggle
is properly
and loaded.
2.
Insert the ReliaTack™ device into an appropriately sized trocar sleeve or larger with the use of a universal sleeve.
UNLOADING
1. IfPush
the left articulate
side of thethe
toggle
button
to expose
the red portion
the buttonuntil
and the
ensure
that angle
the device
is in the
(unarticulated)
3.
necessary,
device
by turning
the articulation
knobofclockwise,
desired
is reached.
Thestraight
ReliaTack™
articulatingposition.
reloadable fixation
device
articulates
to 65lock
degrees.
2. Pull and
hold theupblue
switch button, located on top of the instrument, in the back position.
3. Pull the reload
off of the shaft elbow
of the device.
CAUTION:
The articulating
must be completely visible (beyond the distal end of the trocar sleeve) and not in direct contact
with
viscera
orreload
the abdominal
wall
as the device
is beingcard.
articulated within the body cavity.
4. Insert
the used
into the reload
counter/holder
and storage
4.
Grip the handle ofFOR
the USE
device and press the distal end of the shaft against the mesh at the location where fixation is desired.
INSTRUCTIONS
The device may
be inserted through
a 5 mm
or largerover
(withunderlying
the use of a bone,
converter
or universal
seal) cannula
for usefor
in minimally
invasive procedures.
Do notIn
WARNING:
A minimum
thickness
of tissue
vessels,
or viscera
is needed
full engagement
of the tack.
attempt to insert
or remove
the instrument
from theprosthetic
trocar sleevematerial
if the instrument
in mm)
the articulated
position. Thefull
device
may also be used
in open
procedures.
addition,
thicker
completely
microporous
(over is1.0
may compromise
engagement
of the
tack.
Material
1. Ensure thatshould
the device
is in fire mode,
green toggle
exposed. of the device. Please refer to the tack specification chart for specific
thickness
be carefully
evaluated
priorbutton
to application
minimum
tissue thickness
requirements.
2. Insert the ReliaTack™
device into
an appropriately sized trocar sleeve or larger with the use of a universal sleeve.
5.
external
counterthe
pressure
area immediately
opposite
distal end
thedesired
device when
tacksThe
in aReliaTack™
straight, non-articulated
position. fixation
Moderate
3. Apply
If necessary,
articulate
devicetobytheturning
the articulation
knob the
clockwise,
untilofthe
angle firing
is reached.
articulating reloadable
external
counter pressure
needed for adequate tack deployment in an articulated position.
device articulates
up to 65isdegrees.
CAUTION:
Excessive
force orelbow
torque
maybedamage
the shaft
the device.
CAUTION: The
articulating
must
completely
visibleof(beyond
the distal end of the trocar sleeve) and not in direct contact
with visceraAppropriate
or the abdominal
wall asbethe
devicetoisthe
being
articulated
withinwhen
the body
cavity.
WARNING:
force should
applied
handle
of the device
placing
tacks. Excessive force could result in
4. Grip the to
handle
the device
andthe
pressmaterial
the distal being
end of the
shaft against the mesh at the location where fixation is desired.
damage
the oftissue
and/or
fixated.
6.
To fire the instrument,
the thickness
trigger should
squeezed
an audible
click will confirm
that the
squeeze for
has been
completed. The trigger
WARNING:
A minimum
of be
tissue
overcompletely,
underlying
bone, vessels,
or viscera
is needed
full engagement
of theshould
tack. be
In held
in
the fully squeezed
until the
device is removed
from thematerial
application(over
site. 1.0 mm) may compromise full engagement of the tack. Material
addition,
thicker position
completely
microporous
prosthetic
thickness should
carefully
evaluated
priorthat
to application
refertotoperpendicular
the tack specification
chart
for specific
WARNING:
Prior tobetack
deployment
ensure
the distal tipofofthe
thedevice.
devicePlease
is as close
as possible
to the
targeted
minimum
tissue thickness
requirements.
tissue
to facilitate
appropriate
insertion of the tack. After tack deployment confirm full insertion of the tack into the mesh and
5. Apply the
external
counterof
pressure
to theshould
area immediately
opposite
distal end
of thematerial
device when
firingfixated.
tacks in a straight, non-articulated position. Moderate
tissue,
shoulder
the tack
be flush with
thethe
surface
of the
being
external
pressure
needed
tack deployment
andevice
articulated
position.
7.
Releasecounter
the trigger
fully.isThe
next for
tackadequate
reloads automatically,
andinthe
is ready
for the deployment of the next tack.
CAUTION: squeezes
Excessive
or to
torque
mayfire
damage
theThe
shaft
of the
device.is dependent on the number of tacks, 5, 8, or 10.
Subsequent
areforce
required
completely
the reload.
number
of squeezes
8.
After the reload
has been completely
fired, be
straighten
thetoReliaTack™
device,
thewhen
articulation
knobtacks.
counterExcessive
clockwise,force
ensuring
that result
the device
WARNING:
Appropriate
force should
applied
the handle
of by
theturning
device
placing
could
in is not in
direct
contact
with tissue
viscera orand/or
the abdominal
wall andbeing
removefixated.
the instrument from the body cavity to unload the single use reload from the instrument.
damage
to the
the material
The
be reloaded
firedshould
for a total
of 60 tackscompletely,
in a singleanprocedure.
6. Todevice
fire thecan
instrument,
theand
trigger
be squeezed
audible click will confirm that the squeeze has been completed. The trigger should be held
in the fully
position
theor
device
is removed
from the application
site.trocar sleeve if the instrument is in the articulated position.
NOTE:
Do squeezed
not attempt
tountil
insert
remove
the instrument
from the
WARNING:
PriorTEMPERATURE.
to tack deployment
that the
distal tipTO
ofELEVATED
the deviceTEMPERATURES.
is as close to perpendicular as possible to the targeted
STORE
AT ROOM
AVOIDensure
PROLONGED
EXPOSURE
tissue to facilitate appropriate insertion of the tack. After tack deployment confirm full insertion of the tack into the mesh and
DO
NOTthe
USEshoulder
PRODUCTofIFthe
TEMPERATURE
DOTflush
CENTER
tissue,
tack should be
withON
thePACKAGE
surfaceIS
ofBLACK.
the material being fixated.
7. Release the trigger fully. The next tack reloads automatically, and the device is ready for the deployment of the next tack.
Subsequent squeezes are required to completely fire the reload. The number of squeezes is dependent on the number of tacks, 5, 8, or 10.
8. After the reload has been completely fired, straighten the ReliaTack™ device, by turning the articulation knob counter clockwise, ensuring that the device is not in
direct contact with viscera or the abdominal wall and remove the instrument from the body cavity to unload the single use reload from the instrument.
The device can be reloaded and fired for a total of 60 tacks in a single procedure.
NOTE: Do not attempt to insert or remove the instrument from the trocar sleeve if the instrument is in the articulated position.
STORE AT ROOM TEMPERATURE. AVOID PROLONGED EXPOSURE TO ELEVATED TEMPERATURES.
Caution, consult
Do not use if
accompanying
package
DO NOT USE PRODUCT IF TEMPERATURE DOT CENTER ON
PACKAGEisISopened
BLACK.
documents
or damaged
0123
8. After th
direct con
The devic
NOTE: D
STORE A
DO NOT
© 2015 C
Covi
C
www.cov
COVIDIEN
trademar
2015 / 12
hen
months to 5
e procedure
te insertion
rface of the
nal wall while
he entire 5 mm
he length of
efore firing.
valuated prior
external counter pressure is needed for adequate tack deployment in an articulated position.
CAUTION: Excessive force or torque may damage the shaft of the device.
WARNING: Appropriate force should be applied to the handle of the device when placing tacks. Excessive force could result in
damage to the tissue and/or the material being fixated.
6. To fire the instrument, the trigger should be squeezed completely, an audible click will confirm that the squeeze has been completed. The trigger should be held
in the fully squeezed position until the device is removed from the application site.
INSTRUCTIONS FOR USE
WARNING: Prior to tack deployment ensure that the distal tip of the device is as close to perpendicular as possible to the targeted
tissue to facilitate appropriate insertion of the tack. After tack deployment confirm full insertion of the tack into the mesh and
tissue, the shoulder of the tack should be flush with the surface of the material being fixated.
7. Release the trigger fully. The next tack reloads automatically, and the device is ready for the deployment of the next tack.
Subsequent squeezes are required to completely fire the reload. The number of squeezes is dependent on the number of tacks, 5, 8, or 10.
8. After the reload has been completely fired, straighten the ReliaTack™ device, by turning the articulation knob counter clockwise, ensuring that the device is not in
direct contact with viscera or the abdominal wall and remove the instrument from the body cavity to unload the single use reload from the instrument.
The device can be reloaded and fired for a total of 60 tacks in a single procedure.
Page 2 of 2
NOTE: Do not attempt to insert or remove the instrument from the trocar sleeve if the instrument is in the articulated position.
STORE AT ROOM TEMPERATURE. AVOID PROLONGED EXPOSURE TO ELEVATED TEMPERATURES.
DO NOT USE PRODUCT IF TEMPERATURE DOT CENTER ON PACKAGE IS BLACK.
vascular
refully
d/or the
ar. Retraction
Do not use if
package is opened
or damaged
Caution, consult
accompanying
documents
0123
© 2015 Covidien.
Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA.
Covidien Ireland Limited, IDA Business & Technology Park, Tullamore, Ireland.
www.covidien.com
COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. Other brands are
trademarks of a Covidien company, ™* brands are trademarks of their respective owner.
2015 / 12 - 4
19
510(k) Clearance
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center – WO66-G609
Silver Spring, MD 20993-0002
Covidien LLC
Ms. Mary Mellows
Regulatory Affairs Product Manager
60 Middleton Avenue
North Haven, Connecticut 06473
July 17, 2015
Re: K151659
Trade/Device Name: ReliaTack™ Articulating Reloadable Fixation Device
with Deep Purchase Absorbable Tacks
Regulation Number: 21 CFR 878.4750
Regulation Name: Implantable Staple
Regulatory Class: Class II
Product Code: GDW
Dated: June 18, 2015
Received: June 18, 2015
Dear Ms. Mellows:
We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability
warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
it may be subject to additional controls. Existing major regulations affecting your device can be
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
publish further announcements concerning your device in the Federal Register.
Please be advised that FDA’s issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must
comply with all the Act’s requirements, including, but not limited to: registration and listing (21
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
20
510(k) Clearance
Page 2 – Ms. Mary Mellows
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled, Misbranding by reference to premarket notification (21CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the
Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director
Division of Surgical Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
21
510(k) Clearance
22
510(k) Clearance
23
510(k) Clearance
24
510(k) Clearance
25
510(k) Clearance
26
SURGEON REQUEST FORMS
27
27
Innovation that matters
ReliaTack™
Articulating Reloadable Fixation Device
| HERNIA CARE | MESH • FIXATION • PERMACOL™ • DISSECTION
PRODUCT TRIAL REQUEST FORM
I have reviewed / completed the following materials for ReliaTack™ articulating reloadable fixation device with
my Covidien Representative (check):
Product Overview and Technical Specifications Instructions for Use
Pre-Clinical Data and Competitive Information In-Service by Covidien Representative
Animation and Video(s)
The ReliaTack™ articulating reloadable fixation device delivers:
• Superior access — thanks to 65° of articulation£,1
• Stronger fixation — through perpendicular tack deployment†,2
• Lower cost of care — with 5,8, and 10 tack reloads§,3
I evaluated the above materials and I would like to trial/use the ReliaTack™ articulating reloadable fixation device
in my upcoming laparoscopic hernia procedures.
SURGEON:
Signature:
Date:
Name:
COVIDIEN REPRESENTATIVE:
Signature:
Date:
Name:
£ In comparison to AbsorbaTack™ fixation device
† Compared to Absorbable and Permanent Fixation Devices Commercially Available, which include SecureStrap™* device, SorbaFix™* device, OptiFix™* device, Capsure™*
device, ProTack™ device and ReliaTack™ device with Standard Purchase Tacks when the shaft is angled at 30°, 45°, 65° and 90° (bench testing)
§ Based on potential for eliminating contralateral ports and average savings when 31-50 tacks are needed
1. Mesh Overlap Claims Testing Report R0054140 P-Value= 0.007 (March 2014).
2. ReliaTack™ Deep Purchase Tack Shear Pull Test Report RE00010135-1 P-value = 0.00 (October 2015).
3. ReliaTack™ DPT Cost Comparison, ReliaTack Deep Purchase Internal Average Cost Data compared to SecureStrap™* and SorbaFix™* IMS Data
COVIDIEN, COVIDIEN with logo, and COVIDIEN logo are U.S. and internationally registered trademarks of Covidien AG.
Other brands are trademarks of a Covidien company. ©2016 Covidien 1.16 US140302(1)
Innovation that matters
ReliaTack™
Articulating Reloadable Fixation Device
| HERNIA CARE | MESH • FIXATION • PERMACOL™ • DISSECTION
PRODUCT TRIAL REQUEST FORM
I have reviewed / completed the following materials for ReliaTack™ articulating reloadable fixation device with
my Covidien Representative (check):
Product Overview and Technical Specifications Instructions for Use
Pre-Clinical Data and Competitive Information In-Service by Covidien Representative
Animation and Video(s)
The ReliaTack™ articulating reloadable fixation device delivers:
• Superior access — thanks to 65° of articulation£,1
• Stronger fixation — through perpendicular tack deployment†,2
• Lower cost of care — with 5,8, and 10 tack reloads§,3
I evaluated the above materials and I would like to trial/use the ReliaTack™ articulating reloadable fixation device
in my upcoming laparoscopic hernia procedures.
SURGEON:
Signature:
Date:
Name:
COVIDIEN REPRESENTATIVE:
Signature:
Name:
£ In comparison to AbsorbaTack™ fixation device
† Compared to Absorbable and Permanent Fixation Devices Commercially Available, which include SecureStrap™* device, SorbaFix™* device, OptiFix™* device,
Capsure™* device, ProTack™ device and ReliaTack™ device with Standard Purchase Tacks when the shaft is angled at 30°, 45°, 65° and 90° (bench testing)
§ Based on potential for eliminating contralateral ports and average savings when 31-50 tacks are needed
1. Mesh Overlap Claims Testing Report R0054140 P-Value= 0.007 (March 2014).
2. ReliaTack™ Deep Purchase Tack Shear Pull Test Report RE00010135-1 P-value = 0.00 (October 2015).
3. ReliaTack™ DPT Cost Comparison, ReliaTack Deep Purchase Internal Average Cost Data compared to SecureStrap™* and SorbaFix™* IMS Data
COVIDIEN, COVIDIEN with logo, and COVIDIEN logo are U.S. and internationally registered trademarks of Covidien AG.
Other brands are trademarks of a Covidien company. ©2016 Covidien 1.16 US140302(1)
Date:
Innovation that matters
ReliaTack™
Articulating Reloadable Fixation Device
| HERNIA CARE | MESH • FIXATION • PERMACOL™ • DISSECTION
PRODUCT TRIAL REQUEST FORM
I have reviewed / completed the following materials for ReliaTack™ articulating reloadable fixation device with
my Covidien Representative (check):
Product Overview and Technical Specifications Instructions for Use
Pre-Clinical Data and Competitive Information In-Service by Covidien Representative
Animation and Video(s)
The ReliaTack™ articulating reloadable fixation device delivers:
• Superior access — thanks to 65° of articulation£,1
• Stronger fixation — through perpendicular tack deployment†,2
• Lower cost of care — with 5,8, and 10 tack reloads§,3
I evaluated the above materials and I would like to trial/use the ReliaTack™ articulating reloadable fixation device
in my upcoming laparoscopic hernia procedures.
SURGEON:
Signature:
Date:
Name:
COVIDIEN REPRESENTATIVE:
Signature:
Date:
Name:
£ In comparison to AbsorbaTack™ fixation device
† Compared to Absorbable and Permanent Fixation Devices Commercially Available, which include SecureStrap™* device, SorbaFix™* device, OptiFix™* device, Capsure™*
device, ProTack™ device and ReliaTack™ device with Standard Purchase Tacks when the shaft is angled at 30°, 45°, 65° and 90° (bench testing)
§ Based on potential for eliminating contralateral ports and average savings when 31-50 tacks are needed
1. Mesh Overlap Claims Testing Report R0054140 P-Value= 0.007 (March 2014).
2. ReliaTack™ Deep Purchase Tack Shear Pull Test Report RE00010135-1 P-value = 0.00 (October 2015).
3. ReliaTack™ DPT Cost Comparison, ReliaTack Deep Purchase Internal Average Cost Data compared to SecureStrap™* and SorbaFix™* IMS Data
COVIDIEN, COVIDIEN with logo, and COVIDIEN logo are U.S. and internationally registered trademarks of Covidien AG.
Other brands are trademarks of a Covidien company. ©2016 Covidien 1.16 US140302(1)
Innovation that matters
ReliaTack™
Articulating Reloadable Fixation Device
| HERNIA CARE | MESH • FIXATION • PERMACOL™ • DISSECTION
PRODUCT TRIAL REQUEST FORM
I have reviewed / completed the following materials for ReliaTack™ articulating reloadable fixation device with
my Covidien Representative (check):
Product Overview and Technical Specifications Instructions for Use
Pre-Clinical Data and Competitive Information In-Service by Covidien Representative
Animation and Video(s)
The ReliaTack™ articulating reloadable fixation device delivers:
• Superior access — thanks to 65° of articulation£,1
• Stronger fixation — through perpendicular tack deployment†,2
• Lower cost of care — with 5,8, and 10 tack reloads§,3
I evaluated the above materials and I would like to trial/use the ReliaTack™ articulating reloadable fixation device
in my upcoming laparoscopic hernia procedures.
SURGEON:
Signature:
Date:
Name:
COVIDIEN REPRESENTATIVE:
Signature:
Date:
Name:
£ In comparison to AbsorbaTack™ fixation device
† Compared to Absorbable and Permanent Fixation Devices Commercially Available, which include SecureStrap™* device, SorbaFix™* device, OptiFix™* device, Capsure™*
device, ProTack™ device and ReliaTack™ device with Standard Purchase Tacks when the shaft is angled at 30°, 45°, 65° and 90° (bench testing)
§ Based on potential for eliminating contralateral ports and average savings when 31-50 tacks are needed
1. Mesh Overlap Claims Testing Report R0054140 P-Value= 0.007 (March 2014).
2. ReliaTack™ Deep Purchase Tack Shear Pull Test Report RE00010135-1 P-value = 0.00 (October 2015).
3. ReliaTack™ DPT Cost Comparison, ReliaTack Deep Purchase Internal Average Cost Data compared to SecureStrap™* and SorbaFix™* IMS Data
COVIDIEN, COVIDIEN with logo, and COVIDIEN logo are U.S. and internationally registered trademarks of Covidien AG.
Other brands are trademarks of a Covidien company. ©2016 Covidien 1.16 US140302(1)
Innovation that matters
ReliaTack™
Articulating Reloadable Fixation Device
| HERNIA CARE | MESH • FIXATION • PERMACOL™ • DISSECTION
PRODUCT EVALUATION FORM
Surgeon(s):
Hospital:
Date:
ReliaTack™ device and interchangeable absorbable reloads are packaged 6 per box.
RELTACK3X10
RELTACK10R
RELTACK5R
1x handle and 3x 10-tack standard
purchase reloads
10-tack standard purchase reload
5-tack standard purchase reload
RELTACK4XDPT
RELTACK8RDPT
RELTACK5RDPT
1 x handle and 3x 8 and 1x 5 deep
purchase tack reloads
8-tack deep purchase reload
5-tack deep purchase reload
I trialed the ReliaTack™ articulating reloadable fixation device selected above and find it:
Preferred
Acceptable
Needs Further Evaluation
I support the stocking of the product codes listed above:
Yes
No
Needs Further Evaluation
Would you like your fixation device preference changed to ReliaTack™ articulating reloadable fixation device?
Yes
No
Needs Further Evaluation
Surgeon Signature:
Comments:
COVIDIEN, COVIDIEN with logo, and COVIDIEN logo are U.S. and internationally registered trademarks of Covidien AG.
Other brands are trademarks of a Covidien company. ©2016 Covidien 1.16 US140302(1)
Innovation that matters
ReliaTack™
Articulating Reloadable Fixation Device
| HERNIA CARE | MESH • FIXATION • PERMACOL™ • DISSECTION
PRODUCT EVALUATION FORM
Surgeon(s):
Hospital:
Date:
ReliaTack™ device and interchangeable absorbable reloads are packaged 6 per box.
RELTACK3X10
RELTACK10R
RELTACK5R
1x handle and 3x 10-tack standard
purchase reloads
10-tack standard purchase reload
5-tack standard purchase reload
RELTACK4XDPT
RELTACK8RDPT
RELTACK5RDPT
1 x handle and 3x 8 and 1x 5 deep
purchase tack reloads
8-tack deep purchase tack reload
5-tack deep purchase tack reload
I trialed the ReliaTack™ articulating reloadable fixation device selected above and find it:
Preferred
Acceptable
Needs Further Evaluation
I support the stocking of the product codes listed above:
Yes
No
Needs Further Evaluation
Would you like your fixation device preference changed to ReliaTack™ articulating reloadable fixation device?
Yes
No
Needs Further Evaluation
Surgeon Signature:
Comments:
COVIDIEN, COVIDIEN with logo, and COVIDIEN logo are U.S. and internationally registered trademarks of Covidien AG.
Other brands are trademarks of a Covidien company. ©2016 Covidien 1.16 US140302(1)
Innovation that matters
ReliaTack™
Articulating Reloadable Fixation Device
| HERNIA CARE | MESH • FIXATION • PERMACOL™ • DISSECTION
PRODUCT EVALUATION FORM
Surgeon(s):
Hospital:
Date:
ReliaTack™ device and interchangeable absorbable reloads are packaged 6 per box.
RELTACK3X10
RELTACK10R
RELTACK5R
1x handle and 3x 10-tack standard
purchase reloads
10-tack standard purchase reload
5-tack standard purchase reload
RELTACK4XDPT
RELTACK8RDPT
RELTACK5RDPT
1 x handle and 3x 8 and 1x 5 deep
purchase tack reloads
8-tack deep purchase tack reload
5-tack deep purchase tack reload
I trialed the ReliaTack™ articulating reloadable fixation device selected above and find it:
Preferred
Acceptable
Needs Further Evaluation
I support the stocking of the product codes listed above:
Yes
No
Needs Further Evaluation
Would you like your fixation device preference changed to ReliaTack™ articulating reloadable fixation device?
Yes
No
Needs Further Evaluation
Surgeon Signature:
Comments:
COVIDIEN, COVIDIEN with logo, and COVIDIEN logo are U.S. and internationally registered trademarks of Covidien AG.
Other brands are trademarks of a Covidien company. ©2016 Covidien 1.16 US140302(1)
Innovation that matters
ReliaTack™
Articulating Reloadable Fixation Device
| HERNIA CARE | MESH • FIXATION • PERMACOL™ • DISSECTION
PRODUCT EVALUATION FORM
Surgeon(s):
Hospital:
Date:
ReliaTack™ device and interchangeable absorbable reloads are packaged 6 per box.
RELTACK3X10
RELTACK10R
RELTACK5R
1x handle and 3x 10-tack standard
purchase reloads
10-tack standard purchase reload
5-tack standard purchase reload
RELTACK4XDPT
RELTACK8RDPT
RELTACK5RDPT
1 x handle and 3x 8 and 1x 5 deep
purchase tack reloads
8 Deep Purchase Tack reload
5 Deep Purchase Tack reload
I trialed the ReliaTack™ articulating reloadable fixation device selected above and find it:
Preferred
Acceptable
Needs Further Evaluation
I support the stocking of the product codes listed above:
Yes
No
Needs Further Evaluation
Would you like your fixation device preference changed to ReliaTack™ articulating reloadable fixation device?
Yes
No
Needs Further Evaluation
Surgeon Signature:
Comments:
COVIDIEN, COVIDIEN with logo, and COVIDIEN logo are U.S. and internationally registered trademarks of Covidien AG.
Other brands are trademarks of a Covidien company. ©2016 Covidien 1.6 US140302(1)
Innovation that matters
ReliaTack™
Articulating Reloadable Fixation Device
| HERNIA CARE | MESH • FIXATION • PERMACOL™ • DISSECTION
PRODUCT STOCKING REQUEST FORM
I am requesting the ReliaTack™ articulating reloadable fixation device be ordered and stocked in our facility so that I
have consistent access to this device for my laparoscopic hernia procedures. I have had the opportunity to review the
technical information and bench-top testing data and there are a number of reasons that I would like this product to
be available:
The ReliaTack™ articulating reloadable fixation device delivers:
• Superior access — thanks to 65° of articulation£,1
• Stronger fixation — through perpendicular tack deployment†,2
• Lower cost of care — with 5,8, and 10 tack reloads§,3
In summary, Covidien’s new ReliaTack™ articulating reloadable fixation
device improves access to deliver perpendicular tack deployment,
stronger fixation and a lower cost of care.£,†,§,1,2,3
Thank you for reviewing this information. Our hospital should be
among the first to evaluate this device because of its distinct design.
I look forward to using the ReliaTack™ articulating reloadable fixation
device in my upcoming procedures.
Please contact me directly should you have any questions.
Sincerely,
Additional comments:
£ In comparison to AbsorbaTack™ fixation device
† Compared to Absorbable and Permanent Fixation Devices Commercially Available, which include SecureStrap™* device, SorbaFix™* device, OptiFix™* device,
Capsure™* device, ProTack™ device and ReliaTack™ device with Standard Purchase Tacks when the shaft is angled at 30°, 45°, 65° and 90° (bench testing)
§ Based on potential for eliminating contralateral ports and average savings when 31-50 tacks are needed
1. Mesh Overlap Claims Testing Report R0054140 P-Value= 0.007 (March 2014).
2. ReliaTack™ Deep Purchase Tack Shear Pull Test Report RE00010135-1 P-value = 0.00 (October 2015).
3. ReliaTack™ DPT Cost Comparison, ReliaTack Deep Purchase Internal Average Cost Data compared to SecureStrap™* and SorbaFix™* IMS Data
COVIDIEN, COVIDIEN with logo, and COVIDIEN logo are U.S. and internationally registered trademarks of Covidien AG.
Other brands are trademarks of a Covidien company. ©2016 Covidien 1.16 US140302(1)
RELTACK3X10
1x handle and 3x 10-tack standard
purchase reloads
RELTACK10R
10-tack standard purchase reloads
RELTACK5R
5-tack standard purchase reloads
RELTACK4XDPT
1x handle with 3x 8-tack deep
purchase reloads and 1x 5-tack
deep purchase reload
RELTACK8RDPT
8-tack deep purchase reloads
RELTACK5RDPT
5-tack deep purchase reloads
Innovation that matters
ReliaTack™
Articulating Reloadable Fixation Device
| HERNIA CARE | MESH • FIXATION • PERMACOL™ • DISSECTION
PRODUCT STOCKING REQUEST FORM
I am requesting the ReliaTack™ articulating reloadable fixation device be ordered and stocked in our facility so that I
have consistent access to this device for my laparoscopic hernia procedures. I have had the opportunity to review the
technical information and bench-top testing data and there are a number of reasons that I would like this product to
be available:
The ReliaTack™ articulating reloadable fixation device delivers:
• Superior access — thanks to 65° of articulation£,1
• Stronger fixation — through perpendicular tack deployment†,2
• Lower cost of care — with 5,8, and 10 tack reloads§,3
In summary, Covidien’s new ReliaTack™ articulating reloadable fixation
device improves access to deliver perpendicular tack deployment,
stronger fixation and a lower cost of care.£,†,§,1,2,3
Thank you for reviewing this information. Our hospital should be
among the first to evaluate this device because of its distinct design.
I look forward to using the ReliaTack™ articulating reloadable fixation
device in my upcoming procedures.
Please contact me directly should you have any questions.
Sincerely,
Additional comments:
£ In comparison to AbsorbaTack™ fixation device
† Compared to Absorbable and Permanent Fixation Devices Commercially Available, which include SecureStrap™* device, SorbaFix™* device, OptiFix™* device,
Capsure™* device, ProTack™ device and ReliaTack™ device with Standard Purchase Tacks when the shaft is angled at 30°, 45°, 65° and 90° (bench testing)
§ Based on potential for eliminating contralateral ports and average savings when 31-50 tacks are needed
1. Mesh Overlap Claims Testing Report R0054140 P-Value= 0.007 (March 2014).
2. ReliaTack™ Deep Purchase Tack Shear Pull Test Report RE00010135-1 P-value = 0.00 (October 2015).
3. ReliaTack™ DPT Cost Comparison, ReliaTack Deep Purchase Internal Average Cost Data compared to SecureStrap™* and SorbaFix™* IMS Data
COVIDIEN, COVIDIEN with logo, and COVIDIEN logo are U.S. and internationally registered trademarks of Covidien AG.
Other brands are trademarks of a Covidien company. ©2016 Covidien 1.16 US140302(1)
RELTACK3X10
1x handle and 3x 10-tack standard
purchase reloads
RELTACK10R
10-tack standard purchase reloads
RELTACK5R
5-tack standard purchase reloads
RELTACK4XDPT
1x handle with 3x 8-tack deep
purchase reloads and 1x 5-tack
deep purchase reload
RELTACK8RDPT
8-tack deep purchase reloads
RELTACK5RDPT
5-tack deep purchase reloads
Innovation that matters
ReliaTack™
Articulating Reloadable Fixation Device
| HERNIA CARE | MESH • FIXATION • PERMACOL™ • DISSECTION
PRODUCT STOCKING REQUEST FORM
I am requesting the ReliaTack™ articulating reloadable fixation device be ordered and stocked in our facility so that I
have consistent access to this device for my laparoscopic hernia procedures. I have had the opportunity to review the
technical information and bench-top testing data and there are a number of reasons that I would like this product to
be available:
The ReliaTack™ articulating reloadable fixation device delivers:
• Superior access — thanks to 65° of articulation£,1
• Stronger fixation — through perpendicular tack deployment†,2
• Lower cost of care — with 5,8, and 10 tack reloads§,3
In summary, Covidien’s new ReliaTack™ articulating reloadable fixation
device improves access to deliver perpendicular tack deployment,
stronger fixation and a lower cost of care.£,†,§,1,2,3
Thank you for reviewing this information. Our hospital should be
among the first to evaluate this device because of its distinct design.
I look forward to using the ReliaTack™ articulating reloadable fixation
device in my upcoming procedures.
Please contact me directly should you have any questions.
Sincerely,
Additional comments:
£ In comparison to AbsorbaTack™ fixation device
† Compared to Absorbable and Permanent Fixation Devices Commercially Available, which include SecureStrap™* device, SorbaFix™* device, OptiFix™* device,
Capsure™* device, ProTack™ device and ReliaTack™ device with Standard Purchase Tacks when the shaft is angled at 30°, 45°, 65° and 90° (bench testing)
§ Based on potential for eliminating contralateral ports and average savings when 31-50 tacks are needed
1. Mesh Overlap Claims Testing Report R0054140 P-Value= 0.007 (March 2014).
2. ReliaTack™ Deep Purchase Tack Shear Pull Test Report RE00010135-1 P-value = 0.00 (October 2015).
3. ReliaTack™ DPT Cost Comparison, ReliaTack Deep Purchase Internal Average Cost Data compared to SecureStrap™* and SorbaFix™* IMS Data
COVIDIEN, COVIDIEN with logo, and COVIDIEN logo are U.S. and internationally registered trademarks of Covidien AG.
Other brands are trademarks of a Covidien company. ©2016 Covidien 1.16 US140302(1)
RELTACK3X10
1x handle and 3x 10-tack standard
purchase reloads
RELTACK10R
10-tack standard purchase reloads
RELTACK5R
5-tack standard purchase reloads
RELTACK4XDPT
1x handle with 3x 8-tack deep
purchase reloads and 1x 5-tack
deep purchase reload
RELTACK8RDPT
8-tack deep purchase reloads
RELTACK5RDPT
5-tack deep purchase reloads
Innovation that matters
ReliaTack™
Articulating Reloadable Fixation Device
| HERNIA CARE | MESH • FIXATION • PERMACOL™ • DISSECTION
PRODUCT STOCKING REQUEST FORM
I am requesting the ReliaTack™ articulating reloadable fixation device be ordered and stocked in our facility so that I
have consistent access to this device for my laparoscopic hernia procedures. I have had the opportunity to review the
technical information and bench-top testing data and there are a number of reasons that I would like this product to
be available:
The ReliaTack™ articulating reloadable fixation device delivers:
• Superior access — thanks to 65° of articulation£,1
• Stronger fixation — through perpendicular tack deployment†,2
• Lower cost of care — with 5,8, and 10 tack reloads§,3
In summary, Covidien’s new ReliaTack™ articulating reloadable fixation
device improves access to deliver perpendicular tack deployment,
stronger fixation and a lower cost of care.£,†,§,1,2,3
Thank you for reviewing this information. Our hospital should be
among the first to evaluate this device because of its distinct design.
I look forward to using the ReliaTack™ articulating reloadable fixation
device in my upcoming procedures.
Please contact me directly should you have any questions.
Sincerely,
Additional comments:
£ In comparison to AbsorbaTack™ fixation device
† Compared to Absorbable and Permanent Fixation Devices Commercially Available, which include SecureStrap™* device, SorbaFix™* device, OptiFix™* device,
Capsure™* device, ProTack™ device and ReliaTack™ device with Standard Purchase Tacks when the shaft is angled at 30°, 45°, 65° and 90° (bench testing)
§ Based on potential for eliminating contralateral ports and average savings when 31-50 tacks are needed
1. Mesh Overlap Claims Testing Report R0054140 P-Value= 0.007 (March 2014).
2. ReliaTack™ Deep Purchase Tack Shear Pull Test Report RE00010135-1 P-value = 0.00 (October 2015).
3. ReliaTack™ DPT Cost Comparison, ReliaTack Deep Purchase Internal Average Cost Data compared to SecureStrap™* and SorbaFix™* IMS Data
COVIDIEN, COVIDIEN with logo, and COVIDIEN logo are U.S. and internationally registered trademarks of Covidien AG.
Other brands are trademarks of a Covidien company. ©2016 Covidien 1.16 US140302(1)
RELTACK3X10
1x handle and 3x 10-tack standard
purchase reloads
RELTACK10R
10-tack standard purchase reloads
RELTACK5R
5-tack standard purchase reloads
RELTACK4XDPT
1x handle with 3x 8-tack deep
purchase reloads and 1x 5-tack
deep purchase reload
RELTACK8RDPT
8-tack deep purchase reloads
RELTACK5RDPT
5-tack deep purchase reloads
References
1. Mesh Overlap Claims Testing Report R0054140 P-Value= 0.007 (March 2014).
2. ReliaTack™ Deep Purchase Tack Shear Pull Test Report RE00010135-1 P-value = 0.00 (October 2015).
3. ReliaTack™ DPT Cost Comparison, ReliaTack Deep Purchase Internal Average Cost Data compared to SecureStrap™*
and SorbaFix™* IMS Data
4. Clinical Literature Review. Mesh overlap and risk of recurrence in ventral hernia mesh repair. Jan 2012.
5. Liang MK, Clapp ML, Garcia A, Subramania A, Awad SS. Mesh shift following laparoscopic ventral hernia repair.
Journal of Surgical Research. 2012 April 12; 177 (1): E7-E13.
6. Engineering Development of Reliability Testing Report #2165-037-0
(March 2014).
7. IMS Trocar ASP Analysis Evaluates Average Trocar Cost
555 Long Wharf Drive
New Haven, CT
06511
1-800-722-8772
www.covidien.com/reliatack
COVIDIEN, COVIDIEN with logo, and COVIDIEN logo are U.S. and internationally registered trademarks of Covidien AG.
™*
Trademark of its respective owner. Other brands are trademarks of a Covidien company. ©2016 Covidien. 03/2016 P140011a(2) [ref#344280]