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Canada approves cardiac surgery adhesion barrier

This article was originally published in The Gray Sheet

Executive Summary

SyntheMed's Repel-CV bioabsorbable adhesion barrier film, for preventing formation of internal scar tissue after cardiac surgery, gains Canadian approval for pediatric patients July 15. Montreal-based distributor Force3 Medicale will market the device in Canada, where an estimated 2,000 pediatric patients have heart surgery annually, according to SyntheMed CEO Bob Hickey. The firm expects U.S. PMA approval for the pediatric indication by the end of the third quarter following receipt on an "approvable" letter from FDA last November (1"The Gray Sheet" Sept. 24, 2007, p. 6). SyntheMed is simultaneously working to gain FDA approval for an adult indication, which offers a significantly larger market, though Hickey could not offer a timeline
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