Value
Analysis
Brief
LigaSure™
Maryland Jaw
Open / Laparoscopic Sealer / Divider
Table of Contents
2|
INTRODUCTION
Covidien Energy. Performance Amplified.
What Sets Covidien Apart
Covidien Energy: The Portfolio
Why LigaSure™ Technology
3
4
5
6
7
PRODUCT INFORMATION
Product Request Form
Product Introduction
Product Specifications
Key Features & Benefits
8
9
10
11
12
PORTFOLIO ADVANTAGES
Portfolio Consolidation
13
14
COMPETITIVE CROSS REFERENCES
17
APPENDIX
21
APPENDIX
510(k) Clearance
Indications For Use
24
25
27
Introduction
3|
Why Covidien
Energy?
Since 1967, Covidien
Energy has been a catalyst
for innovation and a
standard bearer for
quality.
Connected in purpose
with surgeons, we are
pioneers that apply passion,
ingenuity and hands-on
expertise to consistently
advance energy solutions.
We empower surgeons and
administrators to confidently
deliver their highest level of
performance to enhance
patient outcomes with
solutions for optimal
surgical results.
4|
What Sets
Covidien Apart?
5|
•
Through mission-critical
engagement, we listen and
respond to patient, surgeon and
hospital needs. Our efforts are
consistently directed towards the
same goals as yours.
•
Surgery has to be 100% every time.
We care about our work and hold
ourselves accountable to deliver
excellence. No almost, no pretty
good, no apologies.
•
We always see the potential to
accomplish more. As we look around
the corner, we illuminate the future
and leap ahead of our
competitors.
•
With so much at stake, we endeavor
to embrace ever-greater
challenges. Apply head, heart,
hands and activate Covidien Energy,
a formula for dynamic performance.
•
As an industry leader focused on
performance and results, our
advanced-energy solutions bridge
the modalities from traditional
electro-surgery to ultrasonic and RF
vessel sealing
Covidien offers a comprehensive portfolio of energy solutions that
address the full spectrum of clinical energy needs. We achieve this
by working directly with healthcare professionals around the world to
design and develop technologies that meet their needs in
performance and value.
ForceTriad™ Energy Platform
The ForceTriad™ energy platform offers enhanced monopolar and
bipolar energy and the next generation of LigaSure™ vessel sealing
technology – all in one unit. It’s the industry’s only full-featured
platform with remote software upgrade capabilities. Quality and
compatibility of components is ensured when your electrosurgery
system bears the Covidien name.
LigaSure™ Technology
Since its introduction to the market in 1998, LigaSure™
technology has set the industry standard for vessel
sealing. The technology has been used in more than
eight million procedures, worldwide and is supported by
an ever-growing body of evidence-based research. The
clinical efficacy, consistency and reliability of LigaSure™
products is delivered through a variety of instruments
for use in both laparoscopic and open procedures.
Ultrasonic Energy
The Covidien Sonicision™ cordless ultrasonic
device brings ultrasonic technology, with the
expected reliable performance of Covidien
Energy to the operating theater. Power
efficiency with the award-winning Soncision™
device removes the cords, simplifies set-up,
allows for a reduction in instrument exchanges
and provides more available space in the
operating room without the need for a separate
generator.
6|
Why LigaSure™
Technology
LigaSure™ technology is supported
by over 300 peer-reviewed clinical
studies and over eight million
procedures.
Compared to mechanical ligation
techniques, LigaSure™ technology
has been shown to significantly
reduce:
• Operative blood loss in colorectal
gynecologic and urologic surgery1-6
• Perioperative blood transfusions in
gynecologic, urologic and general
surgery5, 7
• Procedure time in colorectal,
gynecologic and urologic surgery1, 3,
4, 6, 9
•
Length of hospital stay in
gynecologic and urologic surgery3, 10
Compared to other energy-based
modalities, LigaSure™ technology
has been shown to reduce:
• Operative blood loss in colorectal and
gynecologic surgery 11-14
• Procedure time in colorectal and
gynecologic surgery 14
7|
LigaSure™
Maryland jaw
Product
Information
8|
Product Request Form
I am requesting the following instruments be stocked in our facility so that I have consistent access to these
devices for my cases:
 LigaSure™ Maryland jaw 20 cm open sealer/divider (LF1723)
 LigaSure™ Maryland jaw 37 cm laparoscopic/sealer/divider (LF1737)
 LigaSure™ Maryland jaw 44 cm long laparoscopic/sealer/divider (LF1744)
The LigaSure™ Maryland jaw is a multifunctional device that combines one-step sealing and the functionality of
a Maryland dissector, atraumatic grasper and cold scissors with the safety of LigaSure™ technology, which
seals vessels, up to and including 7 mm, lymphatic, pulmonary vasculature and tissue bundles in 2 to 4 seconds
using the ForceTriad™ energy platform. The LigaSure™ Maryland jaw also provides enhanced blunt dissection
and allows for cutting independent of sealing.5
LigaSure™ instruments have been found to:
• Have the highest burst pressure and fastest sealing time, and were highest rated overall compared to Gyrus
PK™*, Harmonic ACE™* and ENSEAL™*1
• Reduce blood loss compared to sutures and clips. 2, 3, 4
• Reduce procedure time compared to sutures. 2, 3
• Reduce patient length of stay compared to sutures2
• More than 300 studies have been published about LigaSure™ technology in peer-reviewed journals.
In addition, user feedback for this device has been positive:
• 100% of surgeons surveyed after using the device believe that the LigaSure™ Maryland jaw device provides
efficiency throughout the procedure.5
• 100% of General surgeons surveyed after using the LigaSure™ Maryland jaw device agreed that it will
reduce instrument exchanges during surgery.5
I am confident in using a technology backed by such a significant body of evidence-based research and positive
peer feedback. Thank you for reviewing this information. Please feel free to contact me if you have any
questions.
Sincerely,
Additional Comments:
References
1.Lamberton GR, Hsi RS, Jin DH, Lindler TU, JellisonFC, Baldwin DD. Prospective comparison of four laparoscopic vessel ligation devices.
J Endourol. 2008;22(10):2307-2312.
2.Ding Z, Wable G, Rane A. Use of Ligasure bipolar diathermy system in vaginal hysterectomy. J Obstet Gynaecol. 2005;25(1):49-51.
3.Levy B, Emery L. Randomized trial of suture versus electrosurgical bipolar vessel sealing in vaginal hysterectomy. Obstet
Gynecol.2003;102(1):147-151.
4.Romano F, Gelmini R, Caprotti R, et al. Laparoscopic splenectomy: ligasure versus EndoGIA: a comparative study. J Laparoendosc
AdvSurg Tech A. 2007;17(6):763-767.
5 Based on independent surgeon feedback collected during Covidien-sponsored labs conducted April 16-18, 2013 and April 30-May 3, 2013.
9|
LigaSure™ Maryland jaw
open/laparoscopic sealer/
divider is a multifunctional
device that delivers
efficiency and versatility by
combining one-step sealing
and the functionality of a
Maryland dissector,
autraumatic grasper, and
cold scissors with the
reliability of LigaSure™
technology.
10 |
In addition to the 37 cm, multiple lengths provide
standardization across procedures15
• 23 cm provides access in deep and confined spaces16
• 44 cm provides additional reach17
Ordering Information
Catalog Number
11 |
Quantity Per Package
Product Description
LF1723
6 each
LigaSure™ Maryland Device – 23 cm
LF1737
6 each
LigaSure™ Maryland Device – 37 cm
LF1744
6 each
LigaSure™ Maryland Device – 44 cm
LigaSure™ Maryland jaw combines
one-step sealing with the
functionality of a Maryland
dissector, atraumatic grasper and
cold scissors with the reliability of
LigaSure™ technology.
EFFICIENT
•
One-step sealing provides efficient
transection speed25
Design allows for minimal steps when
sealing and dividing25
The actions to grasp, seal and cut are
simple and intuitive25
•
•
VERSATILE
•
•
•
Enhanced blunt dissection25
Improved tip visualization25
Reduced instrument exchanges25
MULTIFUNCTIONAL
•
•
12 |
A Maryland dissector, grasper and cold
scissors all from one device25
Consistency, control and safety of
LigaSure™ technology
Portfolio
Advantages
13 |
Surgeon Feedback
After using the LigaSure™ Maryland device25:
•
100% of general surgeons surveyed agreed that it will
reduce instrument exchanges in surgery
•
90% of general surgeons surveyed agreed that the
integrated cutter will reduce the need for additional cold
scissors
•
80% of general surgeons surveyed agreed that the device
will reduce the need for additional dissecting
instruments
•
The majority** of surgeons surveyed agreed that the secure
and atraumatic grasping will reduce the need for an
additional grasper
•
100% of surgeons surveyed after using the instrument
believe that the LigaSure™ Maryland device provides
efficiency throughout the procedure
Potential Cost Savings Example
Average price for disposable device
Number of Maryland dissectors per case
Number of cases per week
Number of operating weeks per year
Cost savings, per year, if eliminated
Maryland Dissector
$84
1
10
50
$42,000
Potential savings
of $116,500 per
account annually!
**17 of the 33 surgeons surveyed
14 |
Grasper
$84
1
10
50
$42,000
Shears
$65
1
10
50
$32,500
Portfolio Consolidation
Replacing duplicate vessel
sealers and disposables with
the LigaSure™ Maryland jaw
could:
Reduce SKU inventory
management
Reduce capital equipment
burden by eliminating
duplicate generators
requiring maintenance and
storage
Reduce the number of
meetings with different
suppliers
Qualify your facility for a
preferred tier pricing
15 |
Product Comparison23-28
LF1737
LigaSure™
Maryland jaw
LF1212
LigaSure™
small jaw
LS1500
LigaSure™
Dolphin Tip
LF1637
LigaSure™
Blunt Tip
Seal Plate
Length (mm)
20.3
17.3
17.0
18.3
Cut Length
(mm)
18.5
15.2
14.0
16.8
22
30
Straight
Straight
12.7
12.7
16.3
14.7
Jaw Curvature
(degrees)
Jaw Aperture
(mm)
LigaSure™
Maryland
jaw
Harmonic™*
Close to the
surface
ENSEAL™*
Gyrus™* Thunderbeat™*
Small Jaw
14 cm
14 cm
15 cm
10 cm (hemostat)
Open standard
23 cm
23 cm
25 cm
24 cm
20 cm (hemostat)
Lap standard
37 cm
36 cm
35 cm
33 cm
35 cm
Lap long
44 cm
45 cm
45 cm
45 cm
45 cm
16 |
Competitive
Cross
References
17 |
LF172319-24
Company
Description
Product
Code
Ethicon
LigaSure™ Maryland jaw
5 mm - 23 cm
Harmonic ACE™* Curved
Shears - 23 cm
Harmonic ACE™* Curved
Shears - 14 cm
Harmonic WAVE™* Open
Shears
Harmonic FOCUS™*
Long Curved Shears
Harmonic Focus™*
Curved Shears, 5 mm - 9
cm
Harmonic ACE™*+
Shears - 23 cm
ENSEAL™* G2 Curved
Tissue Sealer - 14 cm
ENSEAL™* G2 Curved
Tissue Sealer - 25 cm
ENSEAL™* G2 Straight
Tissue Sealer - 14 cm
ENSEAL™* G2 Straight
Tissue Sealer - 25 cm
ENSEAL™* TRIO - 14 cm
Curved Tip
ENSEAL™* TRIO - 25 cm
Curved Tip
Olympus
THUNDERBEAT™*
Instrument, 5 mm - 10 cm TB-0510IC
Covidien
Ethicon
Ethicon
Ethicon
Ethicon
Ethicon
Ethicon
Ethicon
Ethicon
Ethicon
Ethicon
Ethicon
Shaft
Length
(cm)
Shaft
Cut
Diameter Curved Independent
Jaw
(mm)
of Seal
Ultrasonic Generator
LF1723
23 cm
5 mm
Yes
Yes
No
ACE23E
23 cm
5 mm
Yes
No
Yes
ACE14S
14 cm
5 mm
Yes
No
Yes
WAVE18S
18 cm
8.5 mm
No
No
Yes
FCS17
17 cm
N/A
Yes
No
Yes
FCS9
9 cm
5 mm
Yes
No
Yes
HAR23
NSLG2C1
4
NSLG2C2
5
23 cm
5 mm
Yes
No
Yes
14 cm
5 mm
Yes
No
No
25 cm
5 mm
Yes
No
No
NSLG2S14
14 cm
5 mm
No
No
No
NSLG2S25
ETRIO314
H
ETRIO325
H
25 cm
5 mm
No
No
No
14 cm
5 mm
Yes
Yes
No
25 cm
5 mm
Yes
Yes
No
10 cm
5 mm
Yes
No
Yes
TB-0520IC
20 cm
5 mm
Yes
No
Yes
920000PK
24 cm
5 mm
Yes
Yes
No
921015PK
15 cm
10 mm
Yes
Yes
No
3720-000
24 cm
5 mm
Yes
No
No
Olympus
THUNDERBEAT™*
Instrument, 5 mm - 20 cm
PKS™* Cutting Forceps,
5 mm - 24 cm
PKS™* Cutting Forceps,
10mm - 15 cm
PKS™* Dissecting
Forceps, 5 mm - 24 cm
ConMed
Altrus™*, 5 mm - 23 cm
60-9521001
23 cm
5 mm
Yes
No
No
ConMed
Altrus™*, 5 mm - 16 cm
60-9522001
16 cm
5 mm
Yes
No
No
Olympus
Olympus
Olympus
18 |
ForceTriad™
Energy
Platform
Ethicon EndoSurg Gen11
Ethicon EndoSurg Gen11
Ethicon EndoSurg Gen11
Ethicon EndoSurg Gen11
Ethicon EndoSurg Gen11
Ethicon EndoSurg Gen11
Ethicon EndoSurg Gen11
Ethicon EndoSurg Gen11
Ethicon EndoSurg Gen11
Ethicon EndoSurg Gen11
Ethicon EndoSurg Gen11
Ethicon EndoSurg Gen11
USG-400
Ultrasonic
Generator /
ESG-400
Electrosurgery
Generator
USG-400
Ultrasonic
Generator /
ESG-400
Electrosurgery
Generator
PKG400
Workstation
PKG400
Workstation
PKG400
Workstation
Altrus™*
Thermal
Tissue Fusion
SystemEnergy
Source
Altrus™*
Thermal
Tissue Fusion
SystemEnergy
Source
LF173719-24
Company
Covidien
Ethicon
Ethicon
Ethicon
Ethicon
Ethicon
Olympus
Olympus
Cut
Shaft
Shaft Diameter Curved Independent
Product
Code Length (cm)
(mm)
Jaw
of Seal
Ultrasonic
Description
LigaSure™ Maryland jaw 5 mm
- 37 cm
LF1737
Harmonic ACE™* with
Ergonomic Grip
ACE36E
Harmonic ACE™* Shears - 36
cm
HAR36
ENSEAL™* G2 Curved Tissue
NSL
G2C35
Sealer - 35 cm
ENSEAL™* Straight Tissue
NSL
G2S35
Sealer - 35 cm
ENSEAL™* TRIO 35 cm,
ETRIO335
H
Curved Tip
THUNDERBEAT™ 5 mm, 35
cm, Front-actuated Grip
TB0535FC
THUNDERBEAT™* Instrument,
TB0535PC
5 mm - 35 cm
Olympus
THUNDERBEAT™* Instrument,
TB0535IC
5 mm - 35 cm
GYRUS HALO™* PKS™*
HACF053
3
Cutting Forceps
GyRUS PKS Cutting ForcepsOpen
920005PK
PKS Cutting Forceps, 5 mm 33 cm
920005PK
PKS Cutting Forceps, 10 mm 33 cm
921020PK
PKS Dissecting Forceps, 5 mm
- 33 cm
920005PK
ConMed
Altrus, 5 mm - 36 cm
Olympus
Olympus
Olympus
Olympus
Olympus
19 |
60-9522001
37 cm
5 mm
Yes
Yes
No
36 cm
5 mm
Yes
No
Yes
36 cm
N/A
Yes
No
Yes
35 cm
5 mm
Yes
No
No
35 cm
5 mm
No
No
No
35 cm
5 mm
Yes
Yes
No
Generator
ForceTriad™ Energy
Platform
Ethicon Endo-Surg
Gen11
Ethicon Endo-Surg
Gen11
Ethicon Endo-Surg
Gen11
Ethicon Endo-Surg
Gen11
Ethicon Endo-Surg
Gen11
Yes
USG-400 Ultrasonic
Generator/ ESG-400
Electrosurgery
Generator
Yes
USG-400 Ultrasonic
Generator/ ESG-400
Electrosurgery
Generator
35 cm
35 cm
5 mm
5 mm
Yes
Yes
No
No
35 cm
5 mm
Yes
No
Yes
USG-400 Ultrasonic
Generator/ ESG-400
Electrosurgery
Generator
33 cm
5 mm
No
Yes
No
PKG400 Workstation
33 cm
5 mm
No
Yes
No
PKG400 Workstation
33 cm
5 mm
No
Yes
No
PKG400 Workstation
33 cm
10 mm
No
Yes
No
PKG400 Workstation
33cm
5 mm
Yes
No
No
36 cm
5 mm
Yes
No
No
PKG400 Workstation
Altrus Thermal Tissue
Fusion System Energy
Source
LF174419-23
Company
Covidien
Ethicon
Ethicon
Ethicon
Olympus
Olympus
Olympus
Olympus
Olympus
20 |
Product
Code
Description
LigaSure™ Maryland jaw 5 mm 44 cm
LF1744
Harmonic ACE™* Curved
Shears - 45 cm
ACE45E
ENSEAL™* G2 Curved Tissue
Sealer - 45 cm
NSLG2C45
ENSEAL™* G2 Straight Tissue
Sealer - 45 cm
NSLG2S45
THUNDERBEAT™*, 5 mm - 45
cm, Front-Actuated Grip
THUNDERBEAT™* Instrument,
5 mm - 45 cm
TB0545FC
TB0545PC
THUNDERBEAT™* Instrument,
5 mm - 45 cm
TB-0545C
PKS™* Cutting Forceps, 5 mm 45 cm
920010PK
PKS™* Dissecting Forceps, 5
mm - 45 cm
920010PK
Cut
Independent
of Seal
Ultrasonic
Shaft
Length
(cm)
Shaft
Diameter
(mm)
Curved
Jaw
44 cm
5 mm
Yes
Yes
No
45 cm
5 mm
Yes
No
Yes
45 cm
5 mm
No
No
No
45 cm
5 mm
No
No
No
Generator
ForceTriad™ Energy
Platform
Ethicon Endo-Surg
Gen11
Ethicon Endo-Surg
Gen11
Ethicon Endo-Surg
Gen11
Yes
USG-400 Ultrasonic
Generator / ESG-400
Electrosurgery
Generator
Yes
USG-400 Ultrasonic
Generator / ESG-400
Electrosurgery
Generator
45 cm
45 cm
5 mm
5 mm
No
No
No
No
45 cm
5 mm
No
No
Yes
USG-400 Ultrasonic
Generator / ESG-400
Electrosurgery
Generator
45 cm
5 mm
Yes
Yes
No
PKG400 Workstation
45 cm
5 mm
Yes
No
No
PKG400 Workstation
References
21 |
References
1. Targarona, et al. A prospective randomized comparison of conventional electrosurgery, bipolar computercontrolled electrosurgery and ultrasonic dissection. Operative Outcome and Cost analysis. Surgical
Innovation. 2005 Dec; 12(4): 339-344.
2. Manouras, et al. Sutureless open low anterior resection with total mesorectal excision for rectal cancer
with the use of the electrothermal bipolar vessel sealing system. 2007.Med Sci Monit; 13(5): CR224-230.
3. Ding Z, et al. Use of LigaSure™ bipolar diathermy system in vaginal hysterectomy. Journal of Obstetrics
Gynaecology. 2005 Jan; 25(1): 49-51.
4. Levy B, Emery L. Randomized Trial of Suture Versus Electrosurgical Bipolar Vessel Sealing in Vaginal
Hysterectomy. Obstetrics and Gynecology. 2003 Jul; 102(1): 147-151.
5. Tamussino K, et al. Electrosurgical bipolar vessel sealing for radical abdominal hysterectomy. Gynecologic
Oncology. 2005 Feb; 96(2): 320-322.
6. Leonardo C, et al. Laparoscopic nephrectomy using LigaSure™ system: preliminary experience. Journal of
Endourology. 2005 Oct; 19(8): 976-8.
7. Daskalopoulos G et al. Electrothermal bipolar coagulation for radical prostatectomies and cystectomies: a
preliminary case-controlled study. International Urology and Nephrology.2004; 36(2): 181-185.
8. Romano F, et al. Laparoscopic Splenectomy: LigaSure™ versus EndoGIA: A Comparative Study. J
Laparoendoscopic & Adv Surg Techniques. 2007. Vol. 17, No.6.
9. Cronje HS, et al. Electrosurgical bipolar vessel sealing during vaginal hysterectomy. Int J Gynaecol Obstet.
2005 Dec; 91(3): 243-5.
10. Metzelder ML, et al. Laparoscopic nephroureterectomy in children: a prospective study on LigaSure™
versus Clip/Ligation. Eur J Pediatr Surg. 2006 Aug; 16(4): 241-4.
11. Araki Y, et al. Clipless hand-assisted laparoscopic total colectomy using LigaSure™ Atlas. Kurume Medical
Journal. 2004; 51(2): 105-8.
12. Campagnacci R, et al. Electrothermal bipolar vessel sealing device vs. ultrasonic coagulating shears in
laparoscopic colectomies: a comparative study. Surg Endosc. 2007 Feb 8.
13. Takada et al. Comparative study of electrothermal bipolar vessel sealer and ultrasonic coagulating shears
in laparoscopic colectomy. Surgical Endoscopy. 2005; 19:226-228.
14. Demirturk F, et al. Comparison of the use of electrothermal bipolar vessel sealer with harmonic scalpel in
total laparoscopic hysterectomy. J Obst Gynaecol Res. 2007; 33 (3):341-345.
22 |
References
15. Chen, Long H. “LigaSure™ Maryland jaw – Indications for Use; K133338.” 20, Dec. 2013. Print.
16. Internal Testing: “Covidien Maryland Validation Report, R0035742.” Sept. 2013. Print.
17. Compared to standard length laparoscopic devices
18. Internal Testing: “Covidien Bench Testing, R0050236” Dec. 2013-Jan. 2014. Print.
19. Ethicon web site: “Harmonic ACE™*+ Brochure.”16, Jan. 2014.
http://www.ethicon.com/sites/default/files/HARMONIC-ACE-Plus-Brochure.pdf.
20. Ethicon web site: “ENSEAL™ G2 Fact Sheet. 16, Jan. 2014.
http://www.ethicon.com/sites/default/files/products/energy/pdf/Enseal-G2-Tissue-Sealer-Fact-Sheet.pdf
21. Ethicon web site: “HARMONIC ACE™* Curved Shears” 16, Jan. 2014.
http://www.ethicon.com/sites/default/files/HARMONIC-ACE-product-fact-sheet.pdf
22. Olympus web site: “HALO PKS Cutting Forceps.” 16, Jan. 2014.
http://www.olympusamerica.com/msg_section/envision/oneoffpages/files/Halo_PKS_Brochure.pdf
23. Olympus. “Thunderbeat Product Brochure.” May. 2013. Print.
24. Conmed web site: “Altrus Thermal Tissue Fusion.” Aug. 2012. Print.
25. Internal Testing: “Maryland Validation Labs – Houston & Los Angeles.” June. 2013. Print
23 |
Appendix
24 |
510(k) Clearance
25 |
510(k) Clearance
26 |
Indications For Use
27 |
COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and/or internationally registered
trademarks of Covidien AG. ™* Trademark of its respective owner. All other brands are
trademarks of a Covidien company. ©2014 Covidien. 1.14. US130311