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ReGen Biologics’ Collagen Scaffold efficacy data questioned by panel

This article was originally published in The Gray Sheet

Executive Summary

Knee cartilage repair product is safe and promotes soft tissue growth but provides uncertain clinical benefits, based on existing data, FDA's Orthopedic and Rehabilitation Devices Panel concludes at a Nov. 14 meeting in Gaithersburg, Md. While the panel did not take an official vote on approvability of ReGen Biologics' 510(k) application, the advisory group reached a general consensus that "whether it is effective remains to be seen," since "there are holes in the data with regard to its efficacy," summarized Panel Chairman Jay Mabrey, M.D., Baylor University Medical Center. Two previous 510(k) applications for the collagen implant were rejected by FDA due to insufficient data, most recently in September 2007. The panel advised that if FDA opts to clear the implantable surgical mesh, it should make the approval contingent upon surgeon training on device use ("1The Gray Sheet" Nov. 10, 2008, p. 11)
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