Baxter’s Artiss sealant wins FDA clearance for face-lift procedures | Regulatory Roundup

September 6, 2011 By MassDevice staff Leave a Comment

Baxter International Inc. (NYSE: BAX) won an expanded indication for its Artiss fibrin sealant, making it available for use during in sealing tissue flaps during face-lift surgeries.

Artiss first won FDA clearance in 2008 for use in adhering skin grafts in wound beds prepared for treating burns in adults and children over the age of one.

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The sealant is also approved for use in burn, reconstructive and plastic surgeries in 15 European countries, according to a press release.

"In traditional face-lift procedures, sutures are used to close the flap of skin at its edge, often leaving a space underneath the tissue that can lead to post-operative complications," according to the release. "Artiss sets within 60 seconds, giving surgeons time to manipulate and accurately position the skin flap. Artiss contains blood plasma proteins essential to clot formation."

The Deerfield, Ill.-based company recently posted double-digit growth for its second quarter ended June 30, amounting to $629 million in earnings on sales of $3.5 billion, representing an 11 percent increase in sales and a 17 percent increase in profits over the second quarter of 2010.

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