![]() ![]() Cerapedics recently initiated a second investigational device exemption clinical trial to evaluate the safety and efficacy of the P-15 technology compared to autograft in transforaminal lumbar interbody fusion surgery. Prior research indicates that i‑FACTOR Peptide Enhanced Bone Graft is superior to the historical "gold standard" autograft in overall clinical success. I‑FACTOR Peptide Enhanced Bone Graft has a novel mechanism of action (attract, attach, and activate) that induces osteoblast cell proliferation and differentiation to accelerate new bone formation in patients with degenerative disk disease. "The ISASS statement notes that i‑FACTOR Peptide Enhanced Bone Graft is based on a well-established mechanism of action and carries extensive clinical data including level 1 human data that strongly supports its safety and efficacy." "We are very pleased that ISASS has issued this important policy update that differentiates our proprietary biomimetic small peptide (P-15) technology from other bone grafting products that have little or no clinical evidence," said Glen Kashuba, CEO of Cerapedics. Food and Drug Administration (FDA) through the Premarket Approval (PMA) process and supported by level 1 clinical data. The orange bars represent results from female donors and the blue bars represent male donors.Cerapedics, a privately-held orthobiologics company, said the International Society for the Advancement of Spine Surgery (ISASS) has issued a new bone grafting policy with recommendations on usage and payor coverage criterion that features i‑FACTOR Peptide Enhanced Bone Graft as one of only two drug-device combination products approved by the U.S. Insufficient numbers of 76-85-year-old females resulted in exclusion from analysis. Donors were grouped in the age ranges specified. ![]() Osteoinductivity scores for each age group and gender were determined using an in vivo athymic rat assay. Medtronic conducted an extensive study assessing the impact of age and gender on osteoinductivity. Medtronic follows AATB guidelines in sourcing donors and works to maximize the use of donated tissue. Product processing consistency is confirmed via ongoing testing. Through a prospective randomized study of production allograft, we were able to validate that the D-Min™ process yields a consistently osteoinductive product. Controls in the D-Min™ process eliminate many of the variables that can affect the osteoinductivity of demineralized bone matrix. Aseptic processing methods versus those employing ethylene oxide or terminal sterilizationĪt Medtronic, we use our proprietary D-Min™ process to demineralize the allograft tissue that goes into the different Grafton™ DBM forms. ![]() Application of defatting agents such as ethanol.Acid concentration and soak time for demineralization.Our aseptically processed fibers have some of the highest osteoinductive scores † on the market and this interconnected mesh of fibers enhances the osteoconductive potential of the product by providing a path for cellular infiltration.īecause allograft tissue processing, including demineralization, has evolved over time and is performed by numerous processors, it is important to recognize that not all demineralization processes are alike. Medtronic was the first to market with a fiber based DBM. And a fiber technology proven to be osteoconductive in a preclinical outcomes study.Validated process consistently produces an osteoinductive finished allograft.Proven in prospective clinical studies.Grafton™ DBM has been used in over 1.5 million surgeries.Grafton™ DBM has over 25 years of clinical history.The D-Min™ process ensures the viral inactivation and osteoinductivity of demineralized bone matrix. The proprietary demineralization process inactivates viruses while preserving the osteoinductive activity necessary for new bone formation. Medtronic's processing facility, located in Eatontown, New Jersey, is accredited by the American Association of Tissue Banks (AATB), and is committed to providing quality and innovation in its various demineralized bone matrix tissue forms. Contraindications the presence of infection at the transplantation site is a contraindication for the use of this allograft. The product can also be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft. Grafton™ DBM demineralized bone fibers (DBF) can be used in orthopedic or reconstructive bone grafting procedures. ![]()
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