ReGen Biologics’ Collagen Scaffold Goes To FDA Panel Nov. 14
This article was originally published in The Gray Sheet
Executive Summary
FDA's Orthopaedic and Rehabilitation Devices Panel will meet Nov. 14 to review an updated 510(k) submission for ReGen Biologics' Collagen Scaffold knee cartilage repair product
You may also be interested in...
ReGen Biologics’ Collagen Scaffold efficacy data questioned by panel
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)
ReGen Biologics’ Collagen Scaffold efficacy data questioned by panel
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)
Research In Brief
ReGen: ReGen Biologics' Menaflex collagen meniscus implant supports new tissue ingrowth and improves clinical outcomes in patients with a chronic, though not acute, meniscal injury, according to a study published in the July 3 issue of The Journal of Bone and Joint Surgery. The two-arm study included 157 acute meniscus injury patients, who had had no prior surgery, and 154 chronic injury patients, who had had up to three prior meniscal surgical procedures. Patients were randomized to either receive Menaflex or a partial meniscectomy only. Patients were followed for up to seven years. Menaflex promoted a significantly greater increase in meniscal tissue than partial meniscectomy and the implant supported "meniscus-like matrix production and integration" as it is assimilated and resorbed. Patients in the chronic group treated with the device showed a statistically significant recovery of their pre-injury activity level and underwent significantly fewer reoperations than control patients. However, no difference in activity recovery was detected between Menaflex and control in the acute patients. Menaflex is available in Europe, but the company has not yet been able to convince FDA to clear the product as "substantially equivalent" via 510(k), instead insisting that a PMA application is required (1"The Gray Sheet" Oct. 1, 2007, p. 17)