A Medical Device Daily
After two previous failed attempts to win FDA PMA approval for its Menaflex collagen meniscus implant, ReGen Biologics (Hackensack, New Jersey) has finally received 510(k) clearance to market the product, a scaffold designed to reinforce and repair soft tissue knee injuries of the medial meniscus.
The company switched from a PMA (premarket application) – considered the FDA’s most stringent type of marketing review, usually for devices that are used more invasively and with significant risk – to the less arduous 510(k) regulatory pathway.
An FDA advisory committee met in November to review ReGen’s 510(k) application, usually reserved for products for which PMA approvals are sought. And in doing so the agency appeared to be signaling its intent to more closely regulate all medical devices, not just those that come under PMA review (Medical Device Daily, Nov. 18, 2008)
Summarizing the views of the members at the advisory meeting, its chair, Jay Mabrey, MD, of Baylor North Texas Orthopaedic Specialists (Dallas), said, “the panel generally believes that the device is safe, but its effectiveness remains to be seen.” He said “the sense of the panel is that yes, it is as safe and effective.” The panel also generally agreed that the device was appropriate for use in both chronic and acute injuries.
The panel’s conclusions were then taken by the Center for Devices and Radiological Health as support for okay of the clearance. Two years ago, the company decided to opt out of the PMA route (Medical Device Daily, Jan. 5, 2006).
At the time, CEO Gerald Bisbee, Jr., PhD, said the rationale for taking the 510(k) route is based on the fact that predicate devices, including surgical patches recently had been cleared, including two in 2005.
The Menaflex is designed to guide new tissue growth, following removal of damaged meniscus tissue, using the body’s own healing process. It provides a resorbable scaffold for the growth of new tissue in the meniscus.
“We are extremely pleased that the FDA has considered the recommendations of the Orthopaedic and Rehabilitation Devices Advisory Panel in support of our collagen scaffold 510(k) and that the FDA agreed to enable U.S. marketing for this important product,” said Gerald Bisbee, Jr, PhD, CEO and chairman of ReGen. The announcement of FDA clearance, he said, “represents the culmination of many years of effort on the part of the company and the invaluable contribution of many supportive investors, advisors and surgeons, as we sought to bring the Menaflex product to the U.S. market.”
The potential market for ReGen’s Menaflex includes a large portion of the estimated annual 1.3 million partial meniscectomies worldwide. Partial meniscectomies increase for those patients who have had previous procedures. And, about 65% of partial meniscectomies occur on the medial meniscus.
ReGen said that it will seek expansion of the indication for use in the lateral meniscus through a new 510(k) application to be submitted to the FDA, with support by data from its ongoing European post-market study.
Menaflex is marketed in Europe for both medial and lateral indications.
Data backing up ReGen’s claims of efficacy include a recent study of 311 patients with an irreparable injury of the medial meniscus or a previous partial medial meniscectomy, treated by a total of 26 surgeon-investigators at 16 sites.
Patients in the study, titled “Comparison of the Collagen Meniscus Implant with Partial Meniscectomy” received either the collagen meniscus implant, or served as a control subject treated with a partial meniscectomy only.
Patients who had a collagen meniscus implant were required to have second-look arthroscopy at one year to determine the amount of new tissue growth and to perform a biopsy to assess tissue quality.
The study authors concluded that new biomechanically competent meniscus-like tissue forms after placement of a collagen meniscus implant, and use of the implant appears safe.
The implant supports new tissue ingrowth that appears to be adequate to enhance meniscal function as evidenced by improved clinical outcomes in patients with a chronic meniscal injury.
However, “The implant was not found to have any benefit for patients with an acute injury,” the study’s authors wrote in a report published in The Journal of Bone and Joint Surgery.