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ORGANOGENESIS APLIGRAF SKIN GRAFT PMA APPROVABLE FOR VENOUS ULCERS, PANEL SAYS; PRODUCT EFFECTIVE ONLY FOR WOUNDS MORE THAN ONE YEAR OLD

This article was originally published in The Gray Sheet

Executive Summary

Organogenesis's Apligraf (Graftskin) living skin graft is approvable for use in treating partial- and full-thickness skin loss from ulcers of venous etiology, FDA's General and Plastic Surgery Devices Panel concluded in a 5-4 vote at its Jan. 29 meeting in Gaithersburg, Maryland. In recommending approval for the premarket approval application, the advisory committee concurred with company labeling stating that Graftskin is "particularly beneficial" in treating venous ulcers of duration greater than one year.
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