The U.S. Food and Drug Administration (FDA) has shared that the Orthopaedic and Rehabilitation Devices Panel met recently to discuss and make recommendations on scientific issues relevant to FDA’s re-evaluation of the ReGen Collagen Scaffold (CS) device.
The device, marketed as the Menaflex, was cleared by the FDA in K082079 on December 18, 2008, sponsored by ReGen Biologics, Inc.
The panel gave scientific and clinical input on the data that was submitted in the 510(k). The Panel deliberated on the safety and effectiveness of this product as evidenced from data provided from the submitted studies.
Focus
The sponsor and FDA presentations focused on the scientific issues related to the 510(k) review process including the clinical data collected on the subject device. The clinical data were collected in a multi-center study intended to assess the safety and effectiveness of the ReGen CS device. The sponsor claimed substantial equivalence to three main predicate devices with approximately 26 predicate devices mentioned in their submission.
The FDA posed questions to the advisory panel that were aimed at identifying whether or not the indications were a new intended use altering the therapeutic effect and whether or not the technology of the ReGen device raised new types of safety and effectiveness questions compared to the sponsor’s chosen predicate devices.
Findings
As per the information available, the Panel discussion addressed key issues/questions posed by FDA.
“The Panel discussed and decided that there was insufficient evidence that the device, at time zero, reinforces and repairs soft tissue injuries,” stated an official statement.
The Panel decided that the tissues that ultimately grow in place of the device, as it degrades, may serve to partially reinforce and repair in the long-term, but not fully and that the definition of repair and replace should be further defined. The panel stated that the device is a scaffold that fills a void that reconstructs the removed tissue.
The Panel also decided that the anatomic design and comparisons to other products is generally considered safe, but they had concerns about the overall effectiveness. Moreover, the panel determined that the difference in the anatomical design may contain a reasonable amount of stress that has not been adequately assessed. There was a lengthy discussion about tensile strength over time.
The Panel did form a consensus that due to the low number of device failures, the device can be viewed as reasonably safe, but the device’s effectiveness would need to be analysed further. In order to determine effectiveness, the panel stated that follow-ups on participants, further imaging studies and predetermined endpoints would need to be analysed.
