In Brief: Kensey Nash
This article was originally published in The Gray Sheet
Executive Summary
Kensey Nash: Commences an "early ambulation clinical trial" of its 8 French Angio-Seal device for sealing arterial punctures created during angiography and percutaneous transluminal coronary angioplasty procedures. The study will evaluate the ability of the device to reduce patients' time to ambulation following angioplasty and PTCA. American Home Products, Kensey Nash's partner in developing Angio-Seal, will jointly administer the study, which is expected to enroll 340 patients at eight U.S. centers. Results of the study would support a supplemental application to Kensey Nash's pending PMA for Angio-Seal. Kensey Nash says it is working to resolve issues related to an FDA premarket inspection of manufacturing facilities for Angio-Seal. The company received an approvable letter for the device in July 1995...