Cerapedics wins FDA IDE nod for P-15L bone graft trial

Cerapedics said today it won FDA investigational device exemption approval to launch a clinical trial examining the safety and efficacy of its P-15L Peptide Enhanced bone graft. In the trial, the Wesminster, Colo.-based company will explore the use of the P-15L graft as it compares to autografts in transforaminal lumbar interbody fusion procedures meant for treating degenerative disk disease. “Prior research of this proprietary P-15 technology has demonstrated potential benefits in fusion rates, neurological outcomes and safety in cervical and lumbar fusions. We are pleased to participate in a new study evaluating whether similar results can be achieved in a wider range of patients with degenerative disk disease utilizing the next generation P-15L product,” trial principal investigator Dr. Paul Arnold of the University of Kansas Medical Center said in prepared remarks. The P-15L graft is designed based on proprietary synthetic small peptide technology the company developed to support bone growth, attachment and activation, and is intended for use as a substitute for autologous bone. The trial is slated to enroll 364 patients with degenerative disk disease at 30 clinical trial sites in the US, with patients assessed prior to surgery and at six weeks, three months, one year and two years post-surgery. “We are very pleased to be on the verge of initiating this milestone study. We believe the FDA approved study design should allow for rapid enrollment and cle...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Spinal Cerapedics Inc. Source Type: news