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In Brief: Kensey Nash Angio-Seal

This article was originally published in The Gray Sheet

Executive Summary

Kensey Nash Angio-Seal: Firm's puncture closure device gains FDA sign-off on early ambulation claim for use following diagnostic angiography procedures. "Clinical data which supported the change in labeling indicated significantly reduced times to ambulation with a mean of 1.4 hours for Angio-Seal patients vs. 6.6 hours for the manual pressure group," the firm says. The vascular hemostatic sealing product first received premarket approval in September 1996 ("The Gray Sheet" Oct. 7, 1996, I&W-2)...

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