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Surgical adhesive wins EU approval for use in post-browplasty periosteal fixation

Article-Surgical adhesive wins EU approval for use in post-browplasty periosteal fixation

Kennesaw, Ga. — CryoLife Inc., based here, and BioForm Medical, San Mateo, Calif., have announced their receipt of the CE Mark for use of CryoLife’s BioGlue Surgical Adhesive for periosteal fixation following endoscopic browplasty, reports Medical News Today. The CE Mark allows the product to be marketed in the EU.

According to BioForm CEO Steven Basta, this approval is an important step in the overall development strategy to evaluate the use of BioGlue in plastic surgery. “We will not commercially launch BioGlue in the EU until further clinical development is completed, but the product will be available in Europe on a limited basis to early users who will help us in the evaluation and development program,” Medical News Today quotes Mr. Basta as saying.

The development program underway in the EU, he says, will complement the development program for the product in the United States. A U.S. pivotal study of BioGlue for browplasties is planned.

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