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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. 9.Everts PA, Devilee RJ, Oosterbos CJ, Mahoney CB, Schattenkerk ME, Knape JT et al. Autologous platelet gel and fibrin sealant enhance the efficacy of total knee arthroplasty: improved range of motion, decreased length of stay and a reduced incidence of arthrofibrosis. Knee Surgery Sports Traumatology Arthroscopy. 15(7): 888-94, 2007. 10.Berghoff WJ, Pietrzak WS, Rhodes RD. Platelet-rich plasma application during closure following TKA: A retrospective study. Orthopedics. 29(7): 590-606, 2006. 11.Yoo J, Roth K, Hughes B, Fung K, Franklin JH, Lampe HB. The use of autologous plasma adhesives and platelet rich plasma in Hemithyroidectomy: a blinded randomized controlled trial. Presented at the Combined Otolaryngology Spring Meetings. Chicago, IL. May 19-22, 2006. 18.Everts PA, Devilee RJ, Brown MC, van EA, Oosterbos CJ, Stellenboom M et al. Exogenous Application of PlateletLeukocyte Gel during Open Subacromial Decompression Contributes to Improved Patient Outcome. A Prospective Randomized Double-Blind Study. European Surgical Research. 2007. 40(2): 203 -10, 2007. 19.Mishra A, Pavelko T. Treatment of Chronic Elbow Tendinosis With Buffered Platelet-Rich Plasma. American Journal of Sports Medicine. 31(11): 1774-8, 2006. 20.Bielecki TM, Gazdzik TS, Arendt J, Szczepanski T, Krol W, Wielkoszynsky T. Antibacterial effect of platelet gel enriched with growth factors and other active substances. Journal of Bone and Joint Surgery.(British) 89-B(3): 417-420, 2007. 21.Eppley BL, Woodell JE, Higgins J. Platelet quantification and growth factor analysis from platelet-rich plasma: implications for wound healing. Plastic and Reconstructive Surgery. 114(6): 1502-8, 2004. 22.Sanchez M, Anitua E, Azofra J, Andia I, Padilla S, Mujika I. Comparison of surgically repaired achilles tendon tears using platelet-rich fibrin matrices. American Journal of Sports Medicine. 35(2): 245-51, 2007. 23.Tzikas TL. Platelet-rich plasma reduces bleeding, speeds healing. Cosmetic Surgery Times, October 2000. 24.Jackson RF. Using Platelet-Rich Plasma to Promote Healing and Prevent Seroma Formation in Abdominoplasty Procedures. American Journal of Cosmetic Surgery. 20(4):185-94, 2006. 25.Robiony M, Polini F, Costa F, Politi M. Osteogenesis distraction and platelet-rich plasma for bone restoration of the severely atrophic mandible: preliminary results. Journal of Oral Maxillofacial Surgery. 60(6): 630-5, 2002. 26.Garg AK. The use of platelet-rich plasma to enhance the success of bone grafts around dental implants. Dent Implantol ogy Update. 11(3): 17-21, 2000. 27.Ventura A, Terzaghi C, Borgo E, Veroloia C, Gallazzi M, Failoni S. Use of growth factors in ACL Surgery: preliminary study. Journal of Orthopaedic Traumatology. 6: 76-79, 2005. 28.Gosens, Taco. Prospective Randomized Study on Effect of Autologous Platelets Injection in Lateral Epicondylitis Compared to Corticosteroid Injection. Poster presentation at ESSKA in Porto, Portugal, May 2008. 12.Man D, et al. The use of platelet-rich plasma (platelet gel) and platelet-poor plasma (fibrin glue) in cosmetic surgery. Plastic and Reconstructive Surgery. 107(1): 229-237, 2001. 29.Radice, Fernando D, Uso de Concentrado Autologo Rico en Factores de Crecimiento en la Reconstruccion del LCA. Revista Argentina de Artroscopia 2008; 15(1): 31-40. 13.Powell DM, Chang E, Farrior EH. Recovery from deep-plane rhytidectomy following unilateral wound treatment with autologous platelet gel: a pilot study. Archives of Facial Plastic Surgery. 3(4): 245-50, 2001. 30.Data on file at Biomet. 14.Yoo J, Chandarana S, Fung K, Franklin JH. The use of autologous platelet and plasma in neck dissections. Presented at the annual meeting of the American Academy of Otolaryngology – Head and Neck Surgery. Toronto, Ontario, Canada. September 17-20, 2006. 15.Clevens RA. Autologous platelet rich plasma in facial plastic surgery. Presentation. The Eighth International Symposium of Facial Plastic Surgery, New York, NY. May 2002. 16.Brady C, Vang S, Christensen K, Isler J, Vollstedt K, Holt D. Use of autologous platelet gel in bariatric surgery. Journal of Extra Corporeal Technology. 38(2): 161-4, 2006. 17.Fanning J, Murrain L, Flora R, Hutchings T, Johnson JM, Fenton BW. Phase I/II prospective trial of autologous platelet tissue graft in gynecologic surgery. Journal of Minimally Invasive Gynecology. 4(5): 633-7, 2007. 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. All trademarks herein are property of Biomet, Inc. or its subsidiaries unless otherwise indicated. 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. 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