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Cryolife

This article was originally published in The Gray Sheet

Executive Summary

SynerGraft-processed allograft heart valve FDA clearance by May 2004 is projected by the firm following submission of a 510(k) Nov. 3. FDA had requested the premarket submission upon determining that the proprietary depopulation procedure requires the valves to be regulated as devices rather than banked tissue. Cryolife plans to meet with FDA to assess similar regulatory issues with SynerGraft vascular tissue. Seeking to avoid device classification, the firm removed labeling on its vascular tissue for atrial venous access use; the issues were first raised in a February letter from FDA (1"The Gray Sheet" March 10, 2003, p. 29). AV access will be supported under an IDE planned for Q4 2004, however. In addition, Cryolife will submit an IDE for expanded use of BioGlue to seal dura mater in the first quarter of 2004. On Nov. 4, the firm announced Q3 2003 revenues of $15.1 mil., down 10.6%...
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