FDA advisory panel takes 'second look' at meniscal implant clearance data

At an unprecedented meeting, 16 members of the FDA Orthopaedic and Rehabilitation Devices Panel reassessed the safety and efficacy data for a 510(k)-cleared collagen meniscus implant indicated to reinforce and repair medial meniscus soft tissue injuries.

The device in question, the Collagen Scaffold (CS) manufactured by ReGen Biologics Inc. (Hackensack, N.J.) was cleared for marketing in December 2008 after the FDA Orthopaedic and Rehabilitation Devices Panel met in November 2008 to review data on the device.

Approval of the device has been controversial.

FDA officials called the 1-day meeting to request “the assistance of this advisory panel in its re-evaluation of previously submitted data for the ReGen Collagen Scaffold device,” according to an FDA document released for the meeting.

“This is a re-evaluation of a decision, and we will take the recommendations of this panel on the scientific issues,” Mark N. Melkerson, MS, of the FDA, said.

Five questions from FDA

Panel chair and Orthopedics Today Editorial Board Member John D. Kelly IV, MD, and panel members whose experience ranged from orthopedic surgery and musculoskeletal imaging to biostatistics and scientific research heard presentations from ReGen Biologics and the FDA that were similar to those that a panel heard in 2008 prior to clearance of the CS.

For this panel meeting, they discussed five questions from the FDA and whether sufficient data were available to demonstrate the safety and efficacy of the device.

Among the issues the panel debated were whether the CS works as intended through 12-months postoperative follow-up, its similarity to predicate devices cited in the sponsor’s presentation and original submission, whether the CS device’s biomechanical profile demonstrates that it can withstand the stresses it will undergo in the knee and if those claims are adequately supported by sponsor-supplied preclinical test findings.

They also assessed whether missing data from the original clinical study of the CS device pose any issues or preclude scientific conclusions from being drawn about it.

Questions raised

“We question some of the scientific conclusions,” Kelly said, who repeatedly reminded the panel members their charge was evaluating the science behind the implant and not procedural matters related to its clearance.

Kelly said, “I think that there is a little bit of disparity of safety and effectiveness. I think that there is more scientific data for safety than effectiveness.”

Panel member Nakum Karkare, MBBS, D’Orth, found no major flaws with the product. “The device does not fail catastrophically and the clinical results are certainly not bad,” he said.

However, other panelists detailed significant problems with the clinical trial.

Industry representative Robert Durgin, JD, of Biomet, Inc. called the meeting “unprecedented.” He urged the FDA to level the playing field, saying that the sponsor submitted more data for its 510(k) submission than are usually considered for orthopedic device clearances.

“I think it is beyond any question that the data submitted today fits the regulatory definition of valid scientific evidence which includes many types of clinical data that are not randomized [and], for those reasons, would suggest that the clinical data submitted was adequate.”

The panel did not vote during the meeting, and it was unclear at its conclusion what steps the FDA may take in the future.

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