Menaflex Knee Device Under Review
A Food & Drug Administration (FDA) advisory panel will take up ReGen Biologics Inc.’s Menaflex knee device tomorrow. Menaflex, which was approved under the FDA’s 510(K) process, is meant to repair a torn meniscus.
The 510(K) approval proces doesn’t require human clinical trials, and is meant for devices that are substantially similar to products already on the market.
In early testing, ReGen compared Menaflex to surgical meshes used to repair injuries to other parts of the body. According to The Wall Street Journal, the FDA is concerned about such comparisons because, for example, the weight stress on the shoulder is less than that on a person’s knee. The FDA said it also found it difficult to analyze some of ReGen’s data because it wasn’t presented according to recognized guidelines and didn’t follow certain study protocols.
A report issued by the FDA’s Center for Devices last fall found that agency officials repeatedly deviated from procedures in approving Menaflex. According to the report, the FDA’s Congressional Liaison said the pressure put on the agency was “the most extreme he had seen, and the agency’s acquiescence to the company’s demands for access to the commissioner and other officials in the commissioner’s office as unprecedented.” The document also criticized former FDA Commissioner Andrew von Eschenbach for pressuring other FDA officials to act quickly.
