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Guidant's Origin CABG stabilizer/occluder in beta-site testing after 510(k) clearance.

This article was originally published in The Gray Sheet

Executive Summary

GUIDANT's ORIGIN CARDIAC STABILIZER/OCCLUDER IN BETA SITE TESTING at between six and 12 institutions in the U.S. following FDA 510(k) clearance on Aug. 19. Guidant's Origin Medsytems division is conducting the studies to obtain feedback on product design and to determine whether it will sell the dual-use tool -- which is intended for use in coronary artery bypass grafting (CABG) procedures performed on a beating heart -- as a fully disposable product or offer the stabilizing component as a reusable device and the occluding feature as a disposable. The company expects to launch the stabilizer/occluder in early 1998.
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