FDA clears Organogenesis' rotator cuff repair patch:
This article was originally published in Clinica
Organogenesis has received US FDA 510(k) marketing clearance for its rotator cuff repair patch for use in soft tissue reinforcement applications, including certain rotator cuff repair surgeries. The device is comprised of the firm's FortaFlex bioengineered collagen matrix and is the first product developed under Organogenesis' collaboration with Biomet, which will market the product. Rollout of the patch is expected to start in mid-2002. Over 200,000 rotator cuff repair procedures are performed annually in the US, says Canton, Massachusetts-based Organogenesis.