Download GPS® III Gravitational Platelet Separation System

Are you interested
in a Rapid Recovery
for your patient?
GPS III
Gravitational Platelet
Separation System
®
Accelerating the Body’s
Natural Healing Process
BIOLOGICS
Intended for international use only. Indications for use of products and/or therapies contained herein
may not cleared or approved for marketing for use by the United States Food and Drug Administration.
Why Platelets?
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared or
approved for marketing for use by the United States Food and Drug Administration.
VEGF
TGF-ß2
PDGF
EGF
FGF
TGF-ß1
Utilising the GPS® III System the patient’s own platelets, which travel through the blood stream,
can be collected into a highly concentrated formula.
When platelets become activated, growth factors are released and initiate the body’s natural
healing response.
Platelet Derived Growth Factor
(PDGF-aa, PDGF-ab, PDGF-bb)
Vascular Endothelial Growth Factor ( VEGF )
•Promotes angiogenesis
•Stimulates cell replication
•Promotes angiogenesis
Epidermal Growth Factor (EGF )
•Promotes epithelialisation
•Promotes granulation tissue formation
•Promotes cell differentiation and stimulates
re-epithelialisation, angiogenesis and
collagenase activity
Transforming Growth Factor
( TGF-ß1, TGF-ß2)
Fibroblast Growth Factor (FGF )
•Promotes formation of extracellular matrix
•Promotes proliferation of endothelial cells
and fibroblasts
•Regulates bone cell metabolism
•Stimulation of angiogenesis
The Proof
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared or
approved for marketing for use by the United States Food and Drug Administration.
The Proof
Published literature has shown that:
In Hard Tissue
•Concentrated growth factors can improve/accelerate bone repair,1– 3 resulting in fewer re-operations
and quicker mobilisation of the patient
•Concentrated growth factors can decrease the incidence of bone nonunion in fusion procedures 4 – 6
•Concentrated growth factors can reduce the occurrence of sternal infection after median sternotomy 7– 8
In Soft Tissue
•Concentrated growth factors can decrease wound drainage by up to 25%,9 –10 minimising the need
for post-operative blood transfusions
•Concentrated growth factors can reduce swelling,9 –10, 12 –13 resulting in reduced need for pain medication
and improved patient comfort
•Concentrated growth factors can improve tissue remodeling and decrease scarring and fibrosis14 –15
•Concentrated growth factors can help prevent anastomotic leaks and its associated morbidity
after gastric bypass surgery16
•Concentrated growth factors can decrease pain following gynecological surgery by over 50%17
In General
•Concentrated growth factors can improve range of motion by 15%, making an earlier mobilization of the
patient possible, leading to a quicker discharge from the hospital (-20%), which could result in substantial
cost savings in health care 9 –10,16
•Concentrated growth factors can decrease pain,17,19 leading to improved mobilization and earlier return to
full activity
•Concentrated growth factors have been shown to have an antimicrobial effect, and can decrease the risk of
post-operative infections8,18
GPS® III Platelet Separation System
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared or
approved for marketing for use by the United States Food and Drug Administration.
Quality
Biomet Biologics continues to push the envelope to provide the most consistent and efficient platelet
separation system. Biomet Biologics continues the pursuit to provide the highest quality and user-friendly
system. The evidence is in platelet recovery.
Over 90% Platelet Recovery
When evaluating platelet concentration systems, the overall percentage of platelets recovered in a sample of
whole blood is a key variable. This determines the efficiency of a system regardless of the volume of Platelet
Rich Plasma (PRP) produced. Many systems base their platelet count numbers on variable PRP volumes, which
greatly affects the platelet concentration over baseline levels. For example, if 3ml of PRP is processed from 60ml
of blood, the platelet concentration level over baseline will be higher than if 10ml of PRP is processed from the
same volume.
With the GPS® III System, a fixed volume (10% of starting volume) of PRP is processed that will contain over
90% of the available platelets.30 Because of the GPS® III System’s automated separation mechanism, a consistent
platelet concentrate is attainable each and every time.
The higher the platelet recovery the more
efficient the system is in collecting and
concentrating platelets.
Platelet Poor
Plasma (PPP)
Buffy Coat
(Platelets and
White Blood Cells)
Red Blood
Cells
The patent pending fixed dual buoy mechanism is
slanted which creates a reservoir for more efficient
recovery of platelets and white blood cells.
60ml GPS® III Tube
Platelet Increase Over Baseline Level 9.3x30
White Blood Cell Increase Over Baseline Level 5x30
Volume Flexibility
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared or
approved for marketing for use by the United States Food and Drug Administration.
The GPS III System offers three volume options to meet different clinical needs:
®
Mini
Single
Double
Blood Draw
27ml
54ml
54ml per tube = 108ml
ACD-A (Anticoagulant)
3ml
6ml
6ml per tube = 12ml
Platelet Concentrate Volume
3ml
6ml
6ml per tube = 12ml
Preparation of the GPS® III and the Mini GPS® III Systems
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared or
approved for marketing for use by the United States Food and Drug Administration.
Step One: Blood Draw
Attach supplied 18 gauge needle to 60ml syringe. Withdraw
6ml of ACD-A (citrate anticoagulant).
54ml of blood is then drawn from the patient according to
facility protocol.
Mini GPS® III System: Attach supplied 18 gauge needle to
30ml syringe. Withdraw 3ml of ACD-A. 27ml of blood is
then drawn from the patient according to facility protocol.
Step Two: Load Blood
Unscrew cap on center port No.1 and discard green
packaging post.
Slowly load blood into center port.
Remove protective cover on white cap and discard. Screw
white cap onto center port.
Preparation of the GPS® III and the Mini GPS® III Systems
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared or
approved for marketing for use by the United States Food and Drug Administration.
Step Three: Balance
Push Open /Stop button on control panel. The “unlocked”
indicator will illuminate. Turn latch counter-clockwise to open
lid. Place tube into centrifuge.
Fill GPS® III System counterbalance (800-0508) with 60ml of
sterile saline and place into opposite side of centrifuge.
Mini GPS III System: If using the mini kit, mini purple
buckets (7433) must be inserted into the centrifuge.
Mini GPS ® III System: Fill purple mini counterbalance
(800-0505) with 30ml of sterile saline and place into opposite
side of centrifuge.
Step Four: Spin
PPP Extraction
Close the lid by rotating the lid latch clockwise. “Latched”
indicator will illuminate. Set speed to 3200 RPM and time
to 15 minutes. Press green button to start spin. Once spin
is complete, press red button to illuminate the “Unlocked”
indicator. Twist latch counter-clockwise to open lid.
To extract the platelet poor plasma (PPP), remove yellow cap
on side port No. 2 and connect the 30ml syringe. Slowly tilt
the tube while withdrawing PPP. Replace yellow cap.
®
Preparation of the GPS® III and the Mini GPS® III Systems
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared or
approved for marketing for use by the United States Food and Drug Administration.
Step 5: PRP Suspension and Extraction
Remove red cap on side port No. 3
and connect 10ml syringe. Withdraw
2ml of PRP.
With 10ml syringe attached, suspend
the platelets by shaking the tube for
30 seconds.
Mini GPS® III System: Remove red cap
on side part No. 3 and connect 10ml
syringe. Withdraw 1ml of PRP.
If the pellet between the buoys is
not suspended completely, shake
tube vigorously.
Extract the remaining platelet rich
plasma ( PRP ) contents into the
attached 10ml syringe.
Application possibilities for the GPS® III System
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared or
approved for marketing for use by the United States Food and Drug Administration.
Hard Tissue
Orthopaedic surgery
•Fractures/non-unions/bony defects 3–5
•Spinal surgery 6
Oral surgery
•Mandibular reconstruction 25
•Bone grafts1
•Dental implants 26
Application of platelet gel for sternum repair.
Soft Tissue
Plastic surgery
•Facial laser procedures 23
•Abdominoplasty12,24
•Breast reduction12
Gynecology
•Hysterectomies17
Bariatric Surgery
•Gastric Bypass16
Application of platelet rich plasma ( PRP ) in elbow tendinosis with
Recover® Platelet Separation Kit.
Orthopaedic Surgery
•Total joint replacement 9,10
•Shoulder decompression18
•Tendon ruptures and tendinosis19, 22,28
•ACL 27, 29
Cardio-thoracic surgery
•Sternal repairs 7, 8
Spraying exposed soft and hard tissue surfaces with platelet gel
after placement of total knee prosthesis.
GPS® III and Clotalyst®
Autologous Clotting Factor
Intended for international use only. Indications for use of products and /
or therapies contained herein may not cleared or approved for marketing
for use by the United States Food and Drug Administration.
Clotalyst ® Autologous
Clotting Factor
Platelet Rich Plasma
Blending Connector
(Part No. 800-0204)
ST-3 Tip
(Part No. ST-3 TIP)
ATM100 Tip
(Part No. ATM100)
Blue Sheath
Quality and Simplicity
Redefined with You in Mind.
For optimal clotting with GPS ® III and Clotalyst
Autologous Clotting Factor, use of the ATM100 and
ST- 3 tips are recommended.
ATM100 TIP: The ATM100 tip has a blending channel
that mixes plasma portion with the thrombin before
being sent through a sheath for precise delivery.
ST- 3 TIP: The ST- 3 TIP is used in conjunction with a
blending connector (800-0204). It blends the plasma
and thrombin portions before passing through the
tip, which produces a fanned out spray.
These tips provide the optimal conversion of platelet
rich plasma to platelet gel and platelet poor plasma
to fibrin glue.
(optional)
GPS® III Ordering Information
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared or
approved for marketing for use by the United States Food and Drug Administration.
Mini GPS III Disposable Kit
®
800-0670A
Contents:
One Disposable Mini Separation Tube
One 1ml Syringe
One 10ml Syringe
Two 30ml Syringes
One 18 Gauge 1.5'' Needle
One 30ml Bottle of ACD-A
One Non-Latex Tourniquet 1x18inch
One 18 Gauge InFusion Cannula with Clamp
Two 2x2 Gauze Sterile
One Adhesive Tape 54inch
Four Syringe Tips-Sterile
GPS III Disposable Single Kit
®
800-0675A
Contents:
One Disposable Separation Tube
One 1ml Syringe
One 10ml Syringe
One 30ml Syringe
One 60ml Syringe
One 18 Gauge 1.5'' Needle
One 30ml Bottle of ACD-A
One Non-Latex Tourniquet 1x18inch
One 18 Gauge InFusion Cannula with Clamp
Two 2x2 Gauze Sterile
One Adhesive Tape 54inch
Four Syringe Tips-Sterile
GPS III Disposable Double Kit
®
Contents:
Two Disposable Separation Tubes
One 1ml Syringe
Two 10ml Syringes
Two 30ml Syringes
Two 60ml Syringes
One 18 Gauge 1.5'' Needle
One 30ml Bottle of ACD-A
One Non-Latex Tourniquet 1x18inch
One 18 Gauge InFusion Cannula with Clamp
Two 2x2 Gauze Sterile
One Adhesive Tape 54inch
Seven Syringe Tips-Sterile
Single Kit Contents:
800-0680A
GPS® III Hardware Ordering Information
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared or
approved for marketing for use by the United States Food and Drug Administration.
Description
Catalog Number
GPS® Spare Bucket Kit (Drucker Centrifuge; 2 Blue Buckets)
7431
GPS® Mini Spare Bucket Kit (Drucker Centrifuge; 2 Purple Buckets)
7433
Drucker 230 Volt 50-60 Hz Centrifuge
755VES-230V
Aerosol Regulator without Vent
800-0211
GPS® Mini Non-Sterile Counterbalance (Purple)
800-0505
GPS® Non-Sterile Counterbalance (Blue)
800-0508
GPS® III Accessory Ordering Information
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared
or approved for marketing for use by the United States Food and Drug Administration.
Description
Catalog Number
Dual Spray Applicator Tip
800-0201
Malleable Dual Cannula Tip 20 Gauge x 4 inch Length
800-0202
Malleable Dual Cannula Tip 20 Gauge x 7 inch Length
800-0203
GPS® III Accessory Ordering Information-continued
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared or
approved for marketing for use by the United States Food and Drug Administration.
Description
Catalog Number
Blending Connector Tip Single Cannula
800-0204
Malleable Dual Cannula Tip 20 Gauge x 10 inch Length
800-0206
Malleable Dual Lumen Endoscopic Tip 5mm x 12 inch Length
800-0207
16 inch Manual Endoscopic Rigid Tip 1 to 1 Ratio
800-0208
12 inch Aerosol Endoscopic Rigid Tip 1 to 1 Ratio
( Tubing included)
800-0216
16 inch Aerosol Endoscopic Rigid Tip 1 to 1 Ratio
( Tubing included)
800-0217
Biomet Biologics Manual Spray Applicator Kit ( Tip not included)
Contents include: Two 12ml Syringes, Two 1ml Syringes, Two Syringe
Assembly Sets, Three Liquid Transfer Cups and Lids, One Plastic Tray
800-0250
Aerosol Spray Kit with Two Sets of Syringes and Two Tips
800-0260
Graft Preparation System
800-0300
ATM100 Autologous Thrombin Mixer Tip
ATM100
ST- 3 Tip ( Ten Pack ) to be used with 800-0204
ST-3 TIP
Clotalyst® Ordering Information
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared or
approved for marketing for use by the United States Food and Drug Administration.
Clotalyst Autologous Thrombin Collection System
®
Description
Catalog Number
Clotalyst® Disposable
800-0750
TPD™ Thrombin Reagent (10 Pack )
TPDRS100T
Clotalyst® Heater (Heater Cord included )
800-0755
Clotalyst® Heater Cord
800-0757
Clotalyst® Non-Sterile Counterbalance
800-0760
Drucker 230 Volt 50-60Hz Centrifuge
755VES-230V
NOTES
Intended for international use only. Indications for use of products and/or therapies contained herein may not cleared or
approved for marketing for use by the United States Food and Drug Administration.
Biomet Biologics, Inc. 56 E. Bell Drive P.O. Box 587
Warsaw, Indiana 46581 USA
01-50-1444
Date: 12/07
GPS™ III Platelet Concentrate Separation Kit
with ACD-A
ATTENTION OPERATING SURGEON
FOR INTERNATIONAL USE ONLY
NOTE: FOR SINGLE USE ONLY. Discard the entire disposable kit
after one use by an acceptable disposal method for devices potentially
contaminated with blood products.
DESCRIPTION
The GPS ™ III Platelet Concentrate Separation Kit with ACD-A aids
separation of the patient’s own blood components by density through the
use of a Biomet Biologics centrifuge.
The GPS™ III Platelet Concentrate Separation Kit with ACD-A permits
platelet concentrate to be rapidly prepared from a small volume of the
patient’s blood that is drawn at the time of treatment.
MATERIALS
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 this kit, are packaged, labeled and sterilized as indicated
by their individual labeling. All components in this kit are latex free.
ACD-A is an anticoagulant supplied by Citra Anticoagulants, Inc., Braintree,
MA, and manufactured by Cytosol Laboratories, Inc., Braintree, MA. For
further information regarding ACD-A Anticoagulant, please contact the
supplier at 1-800-299-3411.
The ACD-A included in this kit is only for use with the GPS™ III Platelet
Concentrate Separation Kit.
INDICATIONS FOR USE
The GPS™ III Platelet Concentrate Separation Kit with ACD-A is designed
to be used for the safe and rapid preparation of autologous platelet-richplasma (PRP) from a small sample of blood at the patient’s point of care.
The PRP can be applied to the surgical site as deemed necessary by
clinical use requirements. In addition, it may be used to improve bone
graft handling.
WARNINGS AND PRECAUTIONS
1. Use proper safety precautions to guard against needle sticks.
2. Follow manufacturer instructions when using centrifuge. Use only a
Biomet Biologics centrifuge (GPS™ – IEC centrifuge or the Drucker
Company centrifuge). Outcomes using centrifuges from other
manufacturers are unknown.
3. Do not use sterilized 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 general risks associated with
treatment and the possible adverse effects.
7. Use prepared platelet concentrate material within 4 hours after drawing
blood from patient.
8. The safety and effectiveness of this device for in vivo indications for use
has not been established.
INSTRUCTIONS FOR USE
NOTE: Use standard aseptic technique throughout the following
procedures.
1. DRAW: Draw 6ml of ACD-A into 60ml syringe. Attach to 18-gauge
apheresis needle and prime with ACD-A. Slowly draw 30 to 54ml
of patient’s own blood into the 60ml syringe primed with ACD-A.
Gently,but thoroughly, mix the whole blood and ACD-A upon collection
to prevent coagulation.
2. LOAD: ENSURE BLOOD FROM ONLY ONE PATIENT IS
PROCESSED PER SPIN, and that the platelet separator remains
upright. Unscrew cap on center blood port #1. Remove and discard
cap and green packaging post. Slowly load blood-filled 60ml syringe
(6ml of ACD-A mixed with 30 to 54ml of patient’s whole blood)
into center blood port #1. Unscrew and discard clear protective
inner piece from white cap tethered to port #1. Screw white cap
onto port #1. Place platelet separator filled with anticoagulated
blood in Biomet Biologics centrifuge.
3. BALANCE:
Processing One Platelet Separator
Fill blue GPS™ counterbalance tube (800-0508) with 36-60ml of sterile
saline/water (equal to amount of whole blood plus ACD-A dispensed
in the platelet separator). Place filled counterbalance directly opposite
from the platelet separator in the centrifuge.
Processing Two Platelet Separators
Fill both platelet separators with equal amounts of whole blood plus
ACD-A. Place filled platelet separators directly opposite from each
other in the centrifuge.
4. SPIN: Close centrifuge lid. Set RPM to 3.2 (x 1,000) and the time to 15
minutes. Press the start button. Once spin is complete, open centrifuge.
5. EXTRACT PPP: Unscrew yellow cap on port #2, and save yellow cap.
Connect 30ml syringe to port #2, invert platelet separator, and extract
platelet-poor-plasma (PPP). Remove 30ml syringe from port #2, cap
with a sterile syringe cap, and set aside. Replace yellow cap on port #2.
6. If PRP is desired, follow steps 7 – 8.
7. SUSPEND PRP: Holding platelet separator in the upright position,
unscrew red cap on port #3. Attach 10ml syringe to port #3. Extract 2 ml
of PRP into the 10ml syringe. Leave the syringe attached. Shake platelet
separator gently for 30 seconds.
8. EXTRACT PRP: Immediately after suspending the platelets, extract
remaining PRP into the attached 10ml syringe. Remove 10ml syringe
from port #3, and cap with a sterile syringe cap.
Comments regarding this device can be directed to Attn: Regulatory Dept,
Biomet, Inc. P.O. Box 587, Warsaw, IN 46581 USA. FAX: 574-372-3968.
This device is only approved for distribution outside the United States.
Biomet® and all other trademarks herein are the property of Biomet, Inc.
or its subsidiaries.
Authorized Representative: 0086
Biomet U.K., Ltd.
Waterton Industrial Estate
Bridgend, South Wales
CF31 3XA, U.K.
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.
STERILITY
GPS™ III Platelet Concentrate Separation Kit platelet separator is sterilized
by exposure to a minimum dose of 25 kGy gamma irradiation. All other
GPS™ III Platelet Concentrate Separation Kit components are sterilized by
the respective suppliers using irradiation or ethylene oxide gas (ETO).
Do not re-sterilize. Do not use after expiration date.
Intended for international use only. Indications for use of products
and/or therapies contained herein may not cleared or approved for
marketing for use by the United States Food and Drug Administration.
Biomet Biologics, Inc. 56 E. Bell Drive P.O. Box 587
Warsaw, Indiana 46581 USA
01-50-1446
Date: 12/07
GPS™ III Mini Platelet Concentrate Separation Kit
with ACD-A
ATTENTION OPERATING SURGEON
FOR INTERNATIONAL USE ONLY
NOTE: FOR SINGLE USE ONLY. Discard the entire disposable kit
after one use by an acceptable disposal method for devices potentially
contaminated with blood products.
DESCRIPTION
The GPS™ III Mini Platelet Concentrate Separation Kit with ACD-A aids
separation of the patient’s own blood components by density through the
use of a Biomet Biologics centrifuge.
GPS™ III Mini Platelet Concentrate Separation Kit with ACD-A permits
platelet concentrate to be rapidly prepared from a small volume of the
patient’s blood that is drawn at the time of treatment.
MATERIALS
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 this kit, are packaged, labeled and sterilized as indicated
by the manufacturer’s labeling. All components in this kit are latex free.
ACD-A is an anticoagulant supplied by Citra Anticoagulants, Inc., Braintree,
MA, and manufactured by Cytosol Laboratories, Inc., Braintree, MA. For
further information regarding ACD-A Anticoagulant, please contact the
supplier at 1-800-299-3411.
The ACD-A included in this kit is only for use with the GPS ™ III Mini
Platelet Concentrate Separation Kit.
INDICATIONS FOR USE
GPS™ III Mini Platelet Concentrate Separation Kit with ACD-A is designed
to be used for the safe and rapid preparation of autologous platelet-richplasma (PRP) from a small sample of blood at the patient’s point of care.
The PRP can be applied to the surgical site as deemed necessary by
clinical use requirements. In addition, it may be used to improve bone
graft handling.
WARNINGS AND PRECAUTIONS
1. Use proper safety precautions to guard against needle sticks.
2. Follow manufacturer instructions when using centrifuge. Use only a
Biomet Biologics centrifuge (GPS™ – IEC centrifuge or Drucker
Company centrifuge). Outcomes using centrifuges from other
manufacturers are unknown.
3. Do not use sterilized 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 general risks associated with
treatment and the possible adverse effects.
7. Use prepared platelet concentrate material within 4 hours after drawing
blood from patient.
8. The safety and effectiveness of this device for in vivo indications for use has not been established.
INSTRUCTIONS FOR USE
NOTE: Use standard aseptic technique throughout the following
procedures.
1. DRAW: Draw 3ml of ACD-A into 30ml syringe, attach to 18-gauge
apheresis needle and prime with ACD-A. Slowly draw 15 to 27ml
of patient’s own blood into the 30ml syringe primed with ACD-A.
Gently, but thoroughly, mix the whole blood and ACD-A upon collection
to prevent coagulation.
2. LOAD: ENSURE BLOOD FROM ONLY ONE PATIENT IS
PROCESSED PER SPIN, and that the platelet separator remains
upright. Unscrew cap on center blood port #1. Remove and discard
cap and green packaging post. Slowly load blood-filled 30ml syringe
(3ml of ACD-A mixed with 15 to 27ml of patient’s whole blood)
into center blood port #1. Unscrew and discard clear protective
inner piece from white cap tethered to port #1. Screw white cap
onto port #1. Place platelet separator filled with anticoagulated
blood in Biomet Biologics centrifuge.
3. BALANCE:
Processing One Platelet Separator
Fill purple GPS™ Mini counterbalance tube (800-0505) with 18-30ml of
sterile saline/water (equal to amount of whole blood plus ACD-A
dispensed in the platelet separator). Place filled counterbalance
directly opposite from the platelet separator in the centrifuge.
Processing Two Platelet Separators
Fill both platelet separators with equal amounts of whole blood plus
ACD-A. Place filled platelet separators directly opposite from each
other in the centrifuge.
4. SPIN: Close centrifuge lid. Set RPM to 3.2 (x 1,000) and the time to 15
minutes. Press the start button. Once spin is complete, open centrifuge.
5. EXTRACT PPP: Unscrew yellow cap on port #2, and save yellow cap.
Connect sterile 30ml syringe to port #2, invert platelet separator, and
extract platelet-poor-plasma (PPP). Remove 30ml syringe from port
#2, cap with a sterile syringe cap, and set aside. Replace yellow cap
on port #2.
6. If PRP is desired, follow steps 7 – 8.
7. SUSPEND PRP: Holding platelet separator in the upright position,
unscrew red cap on port #3. Attach 10ml syringe to port #3. Extract 1ml
of PRP into the 10ml syringe. Leave the syringe attached. Shake platelet
separator gently for 30 seconds.
8. EXTRACT PRP: Immediately after suspending the platelets, extract
remaining PRP into the attached 10ml syringe. Remove 10ml syringe
from port #3, and cap with a sterile syringe cap.
Comments regarding this device can be directed to Attn: Regulatory Dept,
Biomet, Inc. P.O. Box 587, Warsaw, IN 46581 USA, FAX: 574-372-3968.
This device is only approved for distribution outside the United States.
Biomet® and all other trademarks herein are the property of Biomet, Inc.
or its subsidiaries.
Authorized Representative: 0086
Biomet U.K., Ltd.
Waterton Industrial Estate
Bridgend, South Wales
CF31 3XA UK
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.
STERILITY
GPS™ III Mini Platelet Concentrate Separation Kit platelet separator is
sterilized by exposure to a minimum dose of 25 kGy gamma irradiation.
All other GPS™ III Mini Platelet Concentrate Separation Kit components are
sterilized by the respective suppliers using irradiation or ethylene oxide gas
(ETO). Do not re-sterilize. Do not use after expiration date.
Intended for international use only. Indications for use of products
and/or therapies contained herein may not cleared or approved for
marketing for use by the United States Food and Drug Administration.
References
1.Marx RE, Carlson ER, Eichstaedt RM, Schimmele SR,
Strauss JE, Georgeff KR. Platelet-rich plasma: Growth factor
enhancement for bone grafts. Oral Surgery Oral Medicine Oral
Pathology Oral Radiology Endodontology. 85(6): 638-46, 1998.
2.Anitua E, Andia I, Ardanza B, Nurden P, Nurden AT. Autologous
platelets as a source of proteins for healing and tissue
regeneration. Journal of Thrombosis Haemostasis. 91: 4-15, 2003.
3.Gandi A, et al. Platelet releasate enhances healing in patients
with non-unions. Presented at the Orthopedic Research Society
Annual Meeting, February 2003.
4.Bibbo C, Bono CM, Lin SS. Union rates using autologous
platelet concentrate alone and with bone graft in high-risk foot
and ankle surgery patients. Journal of Surgical Orthopaedics
Advances.14(1):17-22, 2005.
5.Barrow CR, Pomeroy GC. Enhancement of syndesmotic fusion
rates in total ankle arthroplasty with the use of autologous
platelet concentrate. Foot & Ankle International. 26(6):458-61, 2005.
6.Jenis LG, Banco RJ, Kwon B. A prospective study of Autologous
Growth Factors (AGF) in lumbar interbody fusion.
The Spine Journal. 6(1): 14-20, 2006.
7.Trowbridge CC, Stammers AH, Woods E, Yen BR, Klayman M,
Gilbert C. Use of platelet gel and its effects on infection in
cardiac surgery. Journal of Extracorporeal Technology.
37(4): 381-86, 2005.
8.Khalafi RS, et al. Effect of platelet-rich plasma application on
postoperative outcomes following a CABG. Presented at
the 18th WCCTS Meeting in Kos, Greece, May 2008.
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