FDA Clears United States Surgical Tissue Adhesive For Sale in US

From: Kath Findlay (kath.findlay@adhesions.org.uk)
Thu Oct 3 22:34:36 2002


FDA Clears United States Surgical Tissue Adhesive For Sale in US

NEW YORK (Reuters Health) Sept 09 - United States Surgical, a division of Tyco Healthcare Group LP, said on Monday that its Indermil (n-Butyl-2-Cyanoacrylate) tissue adhesive has been cleared by US regulators for the closure of topical skin incisions and lacerations.

According to United States Surgical, Indermil is a clear adhesive that sheds from a wound in seven to 10 days.

The Norwalk, Connecticut-based company said that the US Food and Drug Administration's approval was based on a study of 1,092 patients and 2,304 wounds. United States Surgical said that Indermil-treated patients exhibited excellent cosmetic results, and that the product enabled faster wound closure, compared with sutures and staples.

Indermil has been available in the UK since 1994 and is currently approved in about 40 countries.


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