docI/C Graft Chamber Product Guide
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I/C Graft Chamber Product Guide
I/C Graft Chamber Product Guide 68-10-226.00 Product Information What is I/C Graft Chamber? A proprietary mix of demineralized bone material and cancellous chips designed to maintain osteoinductive potential and osteoconductive properties. Product Information I/C Graft Chamber Philosophy Flexible: Allows surgeons to use various hydrating options Product Information I/C Graft Chamber Philosophy Cancellous Chips + DBM= Natural Scaffold for Cellular Attachment and vascular in-growth, and exposed natural growth factors with osteoinductive potential Cancellous Chips Demineralized Ground Cortical Bone I/C Graft Chamber Product Information I/C Graft Chamber Philosophy When combined with bone marrow aspirate, the I/C Graft Chamber provides the three necessary mechanism for bone formation: Osteoconductivity Osteoinductive potential Osteogenicity Product Information Sales Tools Available: Size Order Code 5 cc GDS005T 10 cc GDS010T 15 cc GDS015T 2014 List Fee Brochure: I/C Graft Chamber Support Study: DBM Particles and Cancellous Bone Induce Spinal Fusion in the Athymic Rat PLF Model Product Attributes Product Attribute User Benefit Comprised of 100% natural bone matrix which remodels natural during the bone healing process Easy to revise Contains no fillers or carriers Easy to rehydrate, easy to combine with autologous tissue Cancellous chips provides an optimal scaffold for cellular attachment and vascular in-growth Imperative to bone healing process Can be combined with BMA, PRP,Whole Blood or Saline Adaptable to surgeon need and/or preference Can be combined with autologous tissue Adaptable to patient healing needs PAD Prevents tissues from being over or under demineralized; optimal of amount of natural growth factors enhance bone healing Sterile Significantly minimizes risk of disease transmission Competitive fees Patient treatment cost/hospital cost can be reduced Additional Product Details • • • • • • Sterile – SAL 10-6 Freeze Dried Cancellous Chip Size: 1 – 8 mm DBM Particulate Size: 125 – 1000 mm All tissue from same donor DBM Content: 3:5 DBM to Cancellous Chips Ratio – GDS005T: 3 cc DBM, 5 cc Cancellous Chips – GDS010T: 6 cc DBM, 10 cc Cancellous Chips – GDS015T: 9 cc DBM, 15 cc Cancellous Chips Ideal Spinal Clinical Uses • Posterior Lumbar Fusion • Transforaminal/Posterior Lumbar Interbody Fusion • Anterior Cervical Discectomy Fusion • Posterolateral Fusion Complementary Products BMA Needles (from DePuy Synthes Spine) Item Number Description 2761-21-001 BMA Needle 1 – Hole, 4” Aspiration Kit 2761-23-001 BMA Needle 3 – Hole, 4” Aspiration Kit 2761-23-201 BMA Needle 3 – Hole, 6” Aspiration Kit 2761-24-001 BMA Needle 1 – Hole, 4” Aspiration Kit 2761-24-002 BMA Needle 3 – Hole, 4” Aspiration Kit 2761-24-202 BMA Needle 3 – Hole, 6” Aspiration Kit Preparations for Use • Remove lid – Careful not to remove end cap Preparations for Use • Fill chamber with desired amount of graft materials – Patient bone – BMA • Use at least 1 cc of BMA per cc of graft Preparations for Use • Remove end cap • Use plunger from 15 cc syringe to deliver graft material • Note: syringe is not included with I/C Graft Chamber Preparations for Use • If the graft is not clotted, graft handling and containment may be compromised. • Material is freeze-dried and wicks fluid. Additional 0.5 to 1 cc of fluid may be necessary to avoid dry spots. Positioning and Competitive Information I/C Graft Chamber Pros • PAD Technology – Targets optimal residual calcium for increased osteoinductivity, and reduces variability of the final product • Hydrophylic – Doesn’t contrain a carrier, thus able to absorb bioactive fluids • Sterile – Allowash XG Technology = SAL 10-6 Cons • Handling of a preshaped graft may be more desirable • Plunger is not included Positioning and Competitive Information DBMs Pros • Cost effective • Good handling Cons • Not all DBMs yield consistent or the optimal residual calcium level which affects osteoinductivity • Not all DBMs are sterile – Grafton and DBX are only SAL 10-3 Positioning and Competitive Information DBM Strips and Shapes Pros • Good handling • Minimal manipulation required Cons • Cannot be mixed with patients’ own autograft • Not all DBMs yield consistent or the optimal residual calcium level which affects osteoinductivity • Not all DBMs are sterile – Grafton and DBX are only SAL 10-3 Positioning and Competitive Information Synthetic Strips and Shapes Pros • Good handling • Minimal manipulation required Cons • Cannot be mixed with patients’ own autograft • Not osteoinductive • Expensive Allowash 1. Bioburden Control 2. Bioburden Assessment 3. Minimized Contamination 4. Rigorous Cleaning 5. Disinfection and Rinsing 6. Terminal Sterilization ® XG ® PAD • Studies show residual calcium in the 1 – 4 % range provides the most osteoinductive potential • Patented, precision processing to optimize osteoinductivity Marketing Collateral and Support • • • • Brochure White Paper Product Guide LifeNet Health Guide
