ReGen Biologics hasn't provided enough data to show that its collagen scaffold knee device is safe, the FDA says in documents posted ahead of a closely watched advisory panel meeting next Tuesday to reevaluate the company's Menaflex device.
Menaflex is a resorbable collagen-based surgical mesh composed primarily of type I collagen. It reinforces damaged or weakened tissue and provides a resorbable scaffold for replacement by the patient's own tissue. It is intended for use in the treatment of medial meniscus injuries. Menaflex was cleared by the FDA in December 2008, but is the subject of controversy because of alleged lobbying that may have played a large role in the device's clearance.
In a report released last September, the agency went as far as to admit that there were "multiple departures" from standard procedures during the 17-year review history of the CS device. "Our ability to assess the effect of these departures on the decision-making process was in many cases undermined by the failure of important decision-makers to sufficiently explain and document the bases for their decisions in an administrative record. This failure constitutes a clear deviation from the principles of integrity used in this review and undermines the ability of the agency to counter the suggestion that lobbying on behalf of ReGen affected the decision."
In light of this admission, the FDA is now reanalyzing Menaflex--and it doesn't necessarily like what it sees. "Overall, the FDA believes that sponsor did not provide adequate pre-clinical mechanical testing data to clearly demonstrate safety against mechanical failure of the CS device," the agency says in materials posted ahead of the meeting.
Furthermore, when compared with Restore and TissueMend devices, Menaflex "withstands substantially less force prior to failure," the regulator notes.
Not surprisingly, the company disagrees with the FDA's assessment: "The CS successfully fulfills its intended use of tissue reinforcement as evidenced by significant new tissue filling the meniscal defect and statistically significant improvements in pain, function, self-assessment and activity level from pre-operative status," the devicemaker says in its own pre-meeting documents.
- check out the FDA's briefing materials
- see the company's briefing materials
- read the Wall Street Journal's coverage