Food and Drug Administration (FDA) premarket approval (PMA) application in 2015 only for use in single-level anterior cervical fusion procedures. In the United States, i-FACTOR Peptide Enhanced Bone Graft was approved via a U.S. Cerapedics initial P-15 technology product, i-FACTOR Peptide Enhanced Bone Graft, was approved in the European Union in 2008 and Australia in 2010 for use in the repair of bony voids or defects in orthopedic applications throughout the skeletal system (i.e., the spine and extremities). I-FACTOR+ MATRIX utilizes a small proprietary peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation. “We are excited to announce that i-FACTOR+ Matrix is now fully available in Canada through our distributor Surgi-One and can be used in both spine and general orthopedic applications,” said Glen Kashuba, Chief Executive Officer of Cerapedics, “Canada will be the first market offering the i-FACTOR+ MATRIX product, which leverages the clinically proven P-15 osteogenic cell-binding peptide combined with a collagen carrier for optimized handling.”
#IFACTOR HEALTH FULL#
Underlying inflammatory or tumor disease.Cerapedics, a private ortho-biologics company, today announced the full commercial availability of i-FACTOR+ MATRIX for surgical implantation in Canada.Underlying neurological or neuromuscular disease.Patients who are going to have cemented and / or expansive screws, Peek boxes or another type of material other than Titanium.Patients who have had other types of implants placed, other than Cobalt Chrome bars and Titanium screws and interbody cages.Patients with mental disabilities that make it difficult for them to fill in the questionnaires.Patients who are expected to be unavailable for follow-up.The implants used in the surgery are Cobalt Chrome bars and Titanium screws and interbody cages.Present radiological tests, computed tomography and / or magnetic resonance imaging prior to surgery.(In the event that the patient's circumstances do not allow him to grant consent, this may be provided by the legal representative). Patients who provide their informed consent in writing.In which the minimum number of levels to be instrumented is 5, that is, 4 intervertebral discs. Patients diagnosed with adult deformity, whether due to scoliosis, imbalance, thoracolumbar curves, etc.Spinal Deformity Bone Graft Fusion Rate Quality of Life In the literature there are no articles which identify bone formation with the i-Factor ™ graft in more than 4 instrumented levels, therefore the development of this study will allow assessing the fusion rate and quality of life of patients, which could lead to an improvement in the management and decision-making of surgical procedures, as well as better control of healthcare spending Condition or disease I-Factor ™ Bone Graft (Cerapedics, Inc., Westminster, CO) is a compound formed by peptide P-15 bound to an anorganic bone mineral of bovine origin that is composed of porous and smooth hydroxyapatite (ABM) particles. Furthermore, the problems of bone quality in patients with osteoporosis and the morbidity have forced the orthopedic community to seek other options. However, the source from which to obtain it is limited. Bone grafts and bone substitutes are essential to achieve fusion and manage stability in spinal surgery.Īutologous bone has been considered the "gold-standard" for obtaining a spinal fusion. Why Should I Register and Submit Results?Īdult spinal deformity surgery is a complex procedure that involves many risks and complications.
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