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Closure IDE

This article was originally published in The Gray Sheet

Executive Summary

Firm to begin 150-patient randomized pivotal study for vascular sealant product following FDA go-ahead, announced March 18. The 14-site U.S. and European study will evaluate the sealant's prevention of vascular leakage in patients undergoing femoral-popliteal bypass or AV-access grafting. The study features four- and 12-week follow-up under the guidance of principal investigator Alan Lumsden, MD, Baylor College of Medicine. Closure expects to conclude the study in late 2004, with CE mark approval and PMA filing slated for 2005 (1"The Gray Sheet" Feb. 23, 2004, p. 17)...
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