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FDA okays expanded PAD study

This article was originally published in The Gray Sheet

Executive Summary

Cardiovascular Systems is enrolling patients for a clinical trial evaluating the use of its Orbital Atherectomy System (OAS)in the treatment of peripheral arterial disease. The firm announced FDA go-ahead for the OASIS trial July 19. The catheter-based device removes plaque from peripheral arteries via a diamond-coated crown that creates a lumen twice its size, the firm says. The company estimates more than 12 mil. Americans suffer from PAD, which left untreated could lead to leg amputation...

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