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CryoLife's BioGlue

This article was originally published in The Gray Sheet

Executive Summary

Premarket approval application for all vascular and cardiac repair indications will be submitted to the FDA in early 2001, the firm projects. A recent investigational device exemption application filing outlines planned studies for the use in pulmonary surgical repairs. The trial is expected to be conducted at up to ten medical centers and involve 100 patients. The product is currently available in the U.S. under a humanitarian device exemption (HDE) as an adjunct in the repair of acute thoracic aortic dissections
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