Atherectomy

New Device for Clearing Blocked Arteries in the Legs Receives FDA Clearance for Peripheral Use - Procedures Performed Across the US Within First 48 Hours

Published in Medical Device Business Week, October 10th, 2007

Cardiovascular Systems, Inc. (CSI) announced that the U.S. Food and Drug Administration (FDA) has cleared the use of the Diamondback 360(TM) Orbital Atherectomy System (OAS) for removing plaque blockages in the legs (peripherals) and restoring blood flow. The device offers a promising new alternative for treating complex diffuse disease for patients suffering from Peripheral Arterial Disease PAD.

The clearance follows the successful completion of a rigorous clinical study involving 124 patients, which demonstrated dramatic plaque reduction in leg arteries with lasting results. The OASIS trial exceeded the FDA's Objective Performance Criteria (OPC) on multiple key...

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Source: Medical Device Business Week (2007-10-10)

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