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Organogenesis receives FDA 510(k) clearance to market rotator cuff repair patch.

Organogenesis, Inc., Canton, MA, announced that the FDA has granted 510(k) marketing clearance for the company's rotator cuff repair patch, which is indicated for use in soft tissue reinforcement applications, including certain rotator cuff repair surgeries.

The product is comprised of Organogenesis' FortaFlex bioengineered collagen matrix. The company says the product is the first developed under its collaboration with Biomet, Inc., who will market the product. Under terms of the agreement, Organogenesis will receive a transfer price based on a percentage of the product's selling price.

Each year there are more than 200,000 rotator cuff repair procedures. Organogenesis says its rotator cuff patch provides a resorbable scaffold for the reinforcement of soft tissues which are repaired by sutures and suture anchors during rotator cuff surgery and has been optimized for the strength and tissue interaction requirements for this use.

Contact: Laurie Doyle - (781) 575-0775; Web sites: or
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Comment:Organogenesis receives FDA 510(k) clearance to market rotator cuff repair patch.
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Mar 31, 2002
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