FDA Questions Data Supporting ReGen's Menaflex Ahead Of 510(k) Re-Review

Article reprinted from "The Gray Sheet" - March 22, 2010

FDA raised concerns about the preclinical and clinical data used to support 510(k) clearance of ReGen Biologic's Menaflex knee repair device ahead of an unprecedented March 23 advisory panel to reconsider FDA's original clearance decision. Read more...

FDA Questions Data Supporting ReGen's Menaflex Ahead Of 510(k) Re-Review

Article reprinted from "The Gray Sheet" - March 22, 2010

FDA raised concerns about the preclinical and clinical data used to support 510(k) clearance of ReGen Biologic's Menaflex knee repair device ahead of an unprecedented March 23 advisory panel to reconsider FDA's original clearance decision.

The agency also has concerns with the predicate devices that the firm used to demonstrate the implant's "substantial equivalence" to other currently marketed products, according to panel meeting materials released March 19.

ReGen, however, counters in a March 12 letter to FDA Commissioner Margaret Hamburg that the panel questions are "leading, suggesting negative implications regarding ReGen's data."

FDA's Orthopedic and Rehabilitation Devices panel will meet March 23 in Gaithersburg, Md., to discuss the controversial December 2008 clearance of Menaflex, also known as the ReGen Collagen Scaffold .

Last year, FDA launched the re-review because of concerns that internal and political pressures may have overridden the proper review process.

The agency is separately reviewing whether FDA staffers followed proper review procedures in the Menaflex case (The Gray Sheet' Sept. 28, 2009).

The device has gone to panel once before, in November 2008, just prior to clearance (The Gray Sheet' Dec. 1, 2008).

Panel Will Discuss Clinical Data

The March 23 advisory panel will help FDA reviewers determine whether Menaflex was rightly cleared via 510(k), or whether the device should be up-classified and go through the lengthier and more rigorous pre-market approval process.

Several of FDA's questions to the advisory panel cast doubt on the robustness of ReGen's 510(k) submission data.

The company conducted animal, bench and clinical testing of Menaflex throughout the multi-year review process. The firm originally sought PMA approval, but later switched to the 510(k) route, determining that its product served the same function as other cleared tissue repair devices (The Gray Sheet' March 16, 2009).

The FDA panel materials note several "limitations" with the firm's clinical trial data. For example, all clinical data regarding pain, function, self-assessment and satisfaction endpoints that were collected during the firm's clinical study were not presented in the 510(k) submission according to trial protocol, the agency says.

The study contained an acute arm (no previous surgeries to the meniscus) and a chronic arm (1-3 previous surgeries to the meniscus), but the sponsor only presented data from the chronic arm, plus data from both arms pooled together, FDA said.

There was also missing data on about 15% of patients at two years, FDA noted, without any analysis of how that would have impacted study outcomes. And analyses were not presented at uniform time points for all trial subjects, FDA said.

"Can scientific conclusions be drawn from the data using the clinical endpoints identified, despite the limitations in data?" the agency questioned.

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