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New Device for Clearing Blocked Arteries in the Legs Receives FDA Clearance for Peripheral Use - Procedures Performed Across the US Within First 48 Hours
Date:9/24/2007

MINNEAPOLIS, Sept. 24 /PRNewswire/ -- Cardiovascular Systems, Inc. (CSI) announced today 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 measurable endpoints including the amount of plaque reduced, percentage of patients that did not require repeat procedures, and the overall safety and efficacy of the device. According to Dr. Daniel Dulas of Mercy Hospital and one of the physicians involved in the trial, "These results represent what I believe is a giant step forward in the treatment and care of patients with diffuse vascular disease."

The device differs from existing atherectomy technologies in its ability to remove hard, calcified plaque -- in addition to other common kinds of plaque -- using a unique "orbiting" action. A tiny, diamond-coated crown uses the principles of centrifugal force to rapidly spin or "orbit" at high speeds and sand away plaque, while preserving the healthy tissue of the arterial wall. According to Dr. P.K. Khanna of Eisenhower Hospital, "The resulting particles are about 75% smaller than red blood cells, which eliminates the need for a distal embolization protection device." Existing devices have rarely been able to penetrate and effectively remove the "brick wall" of calcium, which has limited physicians' ability to treat a vast subset of patients.

Within 48 hours of clearance, major medical centers across the country began adopting the new techn
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SOURCE Cardiovascular Systems, Inc.
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