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This article was originally published in The Gray Sheet

Executive Summary

AMERICAN BIOMED RESUMING OMNICATH CLINICAL TRIALS after a one- year hiatus resulting from an FDA objection to a modification to the atherectomy device. American BioMed obtained its original investigational device exemption to study OmniCath in peripheral arteries in June 1991 ("The Gray Sheet" Sept. 16, 1991 p. 20). However, FDA asked the firm to halt its study in August 1992 after learning that the device design had been modified. The agency requested animal data on the new device, and the firm submitted the information to FDA in a May 6 supplement to the IDE. The agency approved the supplement on July 22, clearing the way for studies to recommence. Under the original IDE, two patients were treated with the first OmniCath design and one patient was treated with the revised device, which is designed to improve torque. The IDE supplement allows an additional ten patients to be studied. Clinical trial sites include Conroe Regional Medical Center north of Houston, Baylor University Hospital in Dallas and possibly Methodist Hospital in Houston, pending the institutional review board's approval. On July 23, the Canadian Health Protection Board cleared OmniCath studies in arterial venous dialysis grafts. The approval allows the device to be studied in up to 100 patients, the first ten of which are expected to be treated at Toronto General Hospital. Clearance to begin studies in Canada for peripheral use is anticipated in three to four weeks, the company says.

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