![]() i-FACTOR+ Matrix is the same technology as the P15-L investigational material in the IDE,” said Jeffrey Marx, Ph.D., President and Chief Operating Officer of Cerapedics.ĬAUTION: In the United States, P-15L Bone Graft (i-FACTOR+ Matrix) is an Investigational Product limited by Federal Law to investigational use only. “In addition to the commercial launch in Canada, the latest i-FACTOR+ MATRIX generation is currently being studied in our FDA IDE study, ASPIRE, targeting lumbar fusions (TLIF), as previously announced. 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.” The clinical outcomes for LLIF using these implants and instruments will be reported.Cerapedics, a private ortho-biologics company, today announced the full commercial availability of i-FACTOR+ MATRIX for surgical implantation in Canada. No autograft was harvested from the iliac crest, but local morselized autograft was utilized if available. Bone graft substitute, iFactor (Cerapedics, Colorado USA), was used in all cases. The LLIF technique utilizing K2M’s Ravine retractor system and K2M’s lateral IBD’s, Aleutian (PEEK) and Cascadia (3D printed titanium) will be described (K2M, Leesburg, VA USA). More recent approaches in the retroperitoneal space anteriorly are oblique lumbar interbody fusion (OLIF) anterior to the psoas muscle, and lateral lumbar interbody fusion (LLIF) which is a transpsoas procedure. ![]() Obviously, both PLIF and TLIF are posterior approaches, and ALIF is an anterior approach. ![]() Traditionally, the most common procedures have been posterior lumbar interbody fusion (PLIF), transfacetal lumbar interbody fusion (TLIF), and anterior lumbar interbody fusion (ALIF). These IBD’s have been inserted through a variety of approaches, both by open technique and by minimally invasive surgical (MIS) technique. Introduction: Historically, an interbody device (IBD) has consisted of morselized autograft1, structural autograft, structural allograft, stainless steel ball, threaded titanium cage, polyetheretherketone (PEEK) cage, and more recently 3D printed titanium cage with bioactive surface characteristics and bony ingrowth into IBD interstices. Neurosurgery Department, Royal Hobart Hospital, Hobart, Australia Illawarra Neurosurgery, Wollongong, Australia Department of Neurosurgery, University of Florida, Florida, USA
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