concentration system
Do you want a sticky
gel to improve the
handling of your
bone graft?
Platelet Rich Plasma
Concentrate
High Volume in
5 Minutes
This brochure is for International use only.
It is not for distribution in the United States.
concentration system
The Vortech™ Concentration System produces 30 ml of platelet rich plasma concentrate from only 150 ml of
patients’ own citrated blood.Total operating time will be approximately 5 minutes from the introduction of the
blood into the Vortech™ disposable. When combined with autologous thrombin, the end product is a sticky,
platelet rich plasma gel that can be utilised to accelerate soft tissue and bone healing in a variety of surgical
procedures.The Vortech™ System consists of a base unit and a disposable.
Only the Vortech™ Concentration System can give you the following benefits.
• Simple and quick preparation
• High volume platelet rich plasma concentrate derived from the patients’ own blood
• High fibrinogen concentration
concentration system
Vortech™ Concentration System
Why Platelets?
Utilising the Vortech™ Concentration System, the patient’s own blood is taken and spun down to create a highly
concentrated formula.This high volume formula contains a mixture of concentrated fibrin and platelets.When
the platelets become activated, growth factors are released and initiate the body’s natural healing response.
VEGF
TGF-ß2
PDGF
FGF
TGF-ß1
Platelet Derived Growth Factor
(PDGF-aa, PDGF-ab, PDGF-bb)
•
•
•
•
Stimulates cell replication
Promotes angiogenesis
Promotes epithelialisation
Promotes granulation tissue formation
Transforming Growth Factor
(TGF-ß1, TGF-ß2)
• Promotes formation of extracellular matrix
• Regulates bone cell metabolism
EGF
Vascular Endothelial Growth Factor (VEGF)
• Promotes angiogenesis
Epidermal Growth Factor (EGF)
• Promotes cell differentiation
• Stimulates re-epithelialisation, angiogenesis and
collagenase activity
Fibroblast Growth Factor (FGF)
• Promotes proliferation of endothelial cells
and fibroblasts
• Stimulation of angiogenesis
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1
Why an Elevated Concentration in Fibrinogen?
Fibrin is the naturally optimised carrier for delivery of haematogenic tissue growth factors. During the process
of wound repair, platelets and the coagulation proteins, including fibrinogen, combine to form a fibrin gel.Tissue
growth factors and other active wound healing and signalling cytokines are released by the platelets throughout
the forming fibrin gel, within which they are encapsulated. Upon contraction of the fibrin gel these growth
factors are released into the surrounding tissues.
Fibrin Gel
Vortech™ Concentration System generates platelet rich
plasma concentrate.
A moderate elevated concentration in fibrinogen, as seen in Vortech™ Concentration System (5 to 15 mg/ml),
creates a fibrin gel that is safely below the densities seen to inhibit wound repair, while strong enough to firmly
bind bone graft particles and retain them securely in place throughout the revascularisation period. A Vortech™
coagulum will be resorbed in a physiological way during the tissue healing process.The graft material may be
tightly bound together by the fibrin gel and fixed in place by the formation of new vascular tissue.2
800
700
600
500
400
300
200
100
0
Vortech™ Concentration System bone graft patty
2
concentration system
Blood1
Buffy Coat1
Vortech™1
Simple and Quick Preparation
• User friendly twist on disposable locks onto base unit with ease
• 5 simple steps to produce platelet rich plasma concentrate in approximately 5 minutes
High Volume Platelet Concentrate
• Vortech™ Concentration System quickly produces 30 ml of platelet rich plasma concentrate from 150 ml
of the patients’ own citrated blood
• Provides full array of autologous growth factors
High Fibrinogen Concentration
•
•
•
•
•
•
•
Optimal gel strength
Helps to prevent graft migration
Retains growth factors at desired site
Improves handling when mixed with graft materials due to the 3x concentration of fibrinogen
Useful as an adjunct to sutures and staples
Provides haemostasis
Optimal fibrinogen concentration allows cellular infiltration, providing additional nourishment
Vortech™ Concentration System bone log
Vortech™ Concentration System will enhance
graft containment
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3
Vortech™ Concentration System Preparation
Step One:
Attach disposable onto base by aligning the tabs and twist clockwise until locked. Once disposable is locked into the
proper position, the Ready/Run light turns from red to green.
Step Four:
Push green button on the base to start cycle.Total spin
time is 5 minutes.
4
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Step Two:
Step Three:
1
2
Unscrew red cap on Port “1” and discard. Slowly load
blood filled syringes (a total of 150 ml of citrated blood;
137 ml of patients’ blood mixed with 13 ml of ACD-A
anticoagulant) into port “1”.
Unscrew port “1” and discard.This will release the rotor
and allow it to spin freely.
Step Five:
Once spin is complete, remove blue cap on port “2”. Use 30
ml syringe to extract platelet rich plasma concentrate.
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5
How to use TPD™ Thrombin Processing Device
with Whole Blood
Step One: Preparing TPD™ Thrombin Processing Device for
introducing reagent/blood
6
Remove plastic protectors from both
stopcock valves and attach plunger to
reagent syringe.
While holding TPD™ Thrombin
Processing Device at a 45° angle,
completely inject reagent. NOTE:
When injecting reagent, ensure
internal beads are submerged in
fluid. Remove reagent syringe and
replace blue cap.
While holding the TPD™ Thrombin
Processing Device upright, slowly inject
approximately 11 ml of anticoagulated
blood into TPD™ Thrombin Processing
Device. Note: Fluid level needs to
be at MAX line to ensure proper
functioning of TPD™ Thrombin
Processing Device. DO NOT
OVERFILL. Blood cannot be
drawn back after entering TPD™
Thrombin Processing Device.
Turn stopcock A 90° counterclockwise
so the “OFF” knob points down.Turn
stopcock B 180° counterclockwise so
the “OFF” knob points to the left.
Detach blood syringe and re-attach
yellow luer cap to blood port.
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Remove yellow luer cap over blood
injection port and attach syringe with
11 ml of anticoagulated blood.
Step Two: Processing TPD™ Thrombin Processing Device
Gently invert TPD™ Thrombin Processing
Device at least seven times. Ensure beads
fully mix with fluid.
Place TPD™ Thrombin Processing
Device horizontally on a flat surface,
with beads distributed evenly. Allow
TPD™ Thrombin Processing Device
to rest at 18ºC – 26ºC for 20
minutes. Note: Do not disturb
the TPD™ Thrombin
Processing Device during this
20-minute incubation period.
Step Three: Harvesting Thrombin
Remove white luer cap and attach 20 ml
syringe to thrombin collection port.Turn
stopcock A 90° clockwise so the “OFF”
knob points to the left.
Hold TPD™ Thrombin Processing
Device upright. Pull syringe plunger
back past 20 ml mark. In a few seconds
the thrombin solution will begin to
flow into collection syringe. Continue
harvesting the solution until bubbles
Storage Requirements
After 20 minutes has passed, shake
TPD™ Thrombin Processing Device
vigorously to break up any gel that may
be present and evenly re-distribute
beads. Place horizontally on a flat surface
for an additional 5 minutes. Note: Do
not disturb TPD™ Thrombin
Processing Device during this
5-minute incubation period. After
time has elapsed, shake TPD™ Thrombin
Processing Device vigorously to dislodge
gel.The thrombin is ready to harvest.
are observed in the tubing, which
indicates harvest is complete.Volume
of thrombin produced is at least 7 ml.
Note: A slight resistance will
be felt when thrombin solution
is pulled through internal
filters.
Whole Blood
Anticoagulant
8 –12% ACD-A
Storage Requirements When used immediately or within one hour:
Store at 18 –26ºC
When used after one hour: Store at 2– 6ºC
(up to 4 hours)
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7
Ordering Information
Vortech™ Concentration System
Description
Catalog Number
Vortech™ Disposable Kit
Contents:
Vortech™ Disposable
Two Gauze Sponges
AdhesiveTape
One 18 Gauge Needle
30ml Bottle of ACD-A
Two 30 ml Syringes
Two 60 ml Syringes
Tourniquet
One 18 Gauge Needle Set
800-7600A
Two 60 ml Syringes
18 Gauge Needle
Vortech™
Disposable
Two 30 ml Syringes
Two Gauze
Sponges
Tourniquet
18 Gauge
Needle Set
Adhesive Tape
30 ml ACD-A
8
concentration system
Ordering Information
Vortech™ Concentration System
Description
Catalog Number
Vortech™ Base
7600
Biomet Biologics Manual Spray Applicator Kit (Tip not included)
Two 12 ml Syringes
Two 1 ml Syringes
Two Syringe Assembly Sets
Three Liquid Transfer Cups
One Plastic Tray
800-0250V
Vortech™ Malleable Dual Cannula Tip 20 Gauge x 4 inch Length
800-0202V
Vortech™ Blending Connector Tip Single Cannula
800-0204V
Vortech™ Graft Preparation System
800-0300V
Autologous Thrombin Mixer (Pack of 10 Applicator Tips)
ATM100T
Autologous Thrombin Spray Tip (Pack of 10;To be used with 800–0204V)
ST–3 TIP
Vortech™ Base —
power cord included
(7600)
Blending Connector Tip
Single Cannula
(Includes Two Flexible Sheaths)
(800–0204V)
Spray Applicator Kit — Tip not
included (800–0250V)
Vortech™ Graft
Preparation System
(800–0300V)
Malleable Dual Cannula Tip 20
Gauge x 4 inch Length
(800–0202V)
Autologous Thrombin Mixer
(ATM100T)
Autologous Thrombin
Spray Tip (2)
(ST–3 TIP)
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9
Ordering Information
TPD™ Thrombin Processing Device
Description
Catalog Number
TPD™ Device and Syringes (Box of 10 devices/syringes)
TPD100T
Thrombin Reagent (Box of 10 reagents)
TPDRS100T
TPD™ Device and Syringes
Thrombin Reagent
10
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References
1. Data on file at Biomet. Bench test results are not necessarily indicative of clinical performance.
2. Hood, Andrew G.: Position Paper written on behalf of Interpore Cross, “Moderately Elevated Fibrinogen Is
Necessary for Efficacious Delivery of Topically Applied Autologous Tissue Growth Factors in Bone Fusion.”
February 2003.
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11
Biomet Biologics, Inc.
A Subsidiary of Biomet, Inc.
P.O. Box 587
56 E. Bell Drive
Warsaw, Indiana 46581 USA
01-50-1423
Date: 08/05
VORTECH™ CONCENTRATION SYSTEM,
INCLUDES ACD-A ANTICOAGULANT
ATTENTION OPERATING SURGEON
(For International Use Only)
DESCRIPTION
The Vortech™ Concentration System aids in the concentration of the patient’s
own plasma proteins and platelets by centrifugation, utilizing the Biomet Biologics,
Inc. base unit Part # 7500 or 7600. Red cells are removed by being trapped in a
medical grade foam in the first phase and excess water is removed by mixing
plasma concentrate with desalting beads in the second phase of operation.These
steps are done automatically by the Biomet Biologics, Inc. base unit.
MATERIALS
The materials used in the Vortech™ Concentration System consist of medical
grade polymers, suitable for the use in medical devices. Desalting beads are
porous polyacrylamide beads.The materials used for syringes, needles, tubing,
connectors, and platelet separators consist of medical grade polymers, elastomers
and stainless steels suitable for use in medical devices. Blood draw kit
components, when supplied in the Vortech™ Kit, are packaged, labeled and
sterilized as indicated by their individual labeling.Vortech™ Concentration System
components do not contain Latex.
ACD-A Anticoagulant is supplied by Citra Anticoagulants, Inc. Braintree, MA
manufactured by Cytosol Laboratories, Inc., Braintree, MA. The ACD-A
Anticoagulant in the 30ml container is not cleared or approved for marketing in
the U.S.
INDICATIONS
The Vortech™ Concentration System is designed to be used for
the safe and rapid preparation of autologous platelet-richplasma concentrate from a sample of blood at the patient’s point
of care. The concentrate can be mixed with autograft and
allograft bone prior to application to an orthopedic surgical site
as deemed necessary by clinical use requirements.
STERILITY
Vortech™ Concentration System components are sterilized by exposure to a
minimum dose of 25 kGy gamma radiation. All other Vortech™ components are
sterilized by the respective suppliers using gas plasma radiation or ethylene oxide
gas (ETO). Do not re-sterilize. Do not use after expiration date.
INSTRUCTIONS FOR USE
USING THE VORTECH™ CONCENTRATION SYSTEM
1. ATTACH to base unit by orienting the notches on the side of the disposable
to the pins on the top of the base and while pressing down turn clockwise
until locked into place.
2. DRAW at least 5ml of anticoagulant into two 60ml syringes and 3ml of
anticoagulant into one 30ml syringe. Attach to apheresis needle and prime with
anticoagulant. Draw blood using standard aseptic practice. Draw 55ml of
blood from patient into each 60ml syringe and 27ml of blood from patient into
the 30ml syringe. Gently, but thoroughly mix the whole blood and
anticoagulant upon collection to prevent coagulation.
3. LOAD: Slowly load both blood-filled 60ml syringes (5ml of citrate
anticoagulant and 55ml of whole blood) into port number one. Slowly load the
30ml of whole (3ml of citrate anticoagulant and 27ml of whole blood) into
port number one.
4. REMOVE access port.
5. SPIN: Press green button on front of base unit to start the blood separation
process.
6. EXTRACTION: After the process is complete attach a 30ml syringe to the
center port of disposable and extract the concentrate.
7. Dispose of the Vortech™ container in the appropriate biohazard container.
Comments regarding this device can be directed to Attn: Regulatory Dept,
Biomet. P.O. Box 587,Warsaw, IN 46581 USA, FAX: 574-372-1683.
Authorized Representative:
Biomet U.K., Ltd.
Waterton Industrial Estates
Bridgend, South Wales
CF31 3XA, U.K.
0086
CONTRAINDICATIONS
1. Use as a dialyzer or for dialysis with a dialysate.
2. Direct connection to patient’s vascular system of circulating blood volume.
WARNINGS AND PRECAUTIONS
1. Use proper safety precautions to guard against needle sticks.
2. Follow manufacturer instructions when using the base unit. Use only the
Biomet Biologics, Inc. base unit.
3. Do not use sterile components of this kit if package is opened or damaged.
4. Single use device, do not reuse.
5. The surgeon is to be thoroughly familiar with the equipment and the surgical
procedure prior to using this device.
6. The patient is to be made aware of the general risks associated with treatment
and possible adverse effects.
7. Use prepared plasma concentrate material within 4 hours after drawing blood
from patient.
8. Follow manufacturer package insert for ACD-A Anticoagulant.
POSSIBLE ADVERSE EFFECTS
1. Damage to blood vessels, hematoma, delayed wound healing and/or infection.
2. Temporary or permanent nerve damage that may result in pain or numbness.
3. Early or late postoperative infection.
12
concentration system
The information contained in the package insert was current on the date this brochure
was printed. However, the package insert may have been revised after that date.To
obtain a current package insert, please contact Biomet at the contact information
provided herein.
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13
TPD™ is a trademark of ThermoGenesis Corp.
Vortech™ is a trademark of Biomet
Manufacturing Corp.
This material is intended for the sole use and
benefit of the Biomet Biologics sales force and
physicians. It is not to be redistributed,
duplicated or disclosed without the express
written consent of Biomet.
Responsible Manufacturer
Biomet Biologics, Inc.
A Subsidiary of Biomet, Inc.
P.O. Box 587
56 E. Bell Drive
Warsaw, Indiana 46581-0587
USA
Tel.: +1 574 267 6639
Authorized Representative
Biomet UK, Ltd.
Waterton Industrial Estate
Bridgend, South Wales
CF31 3XA
UK
www.bmetbiologics.com
www.biometeurope.com
Form No.Y-INT-094/101506/M
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