From rxpgnews.com

Cardiology
Orbital Atherectomy System Recieves Authorization for the Treatment of Peripheral Artery Disease
By Cardiovascular Systems, Inc.
May 20, 2005, 08:33

Cardiovascular Systems, Inc. (CSI) today announced that it has received authorization to affix the CE Mark of conformity, allowing European commercialization of the Orbital Atherectomy System(OAS) for treatment of peripheral artery disease. The authorization was issued following a quality management system assessment visit by our notified body BSI, Inc., and a review of the OAS Technical File.

This approval represents an important milestone for CSI as it works toward full worldwide commercialization of the OAS.

Michael J. Kallok, CEO of Cardiovascular Systems, said, "We are pleased to announce that we are now authorized to affix the CE Mark to our device and commercialize it in the European Union. Our product development and manufacturing teams deserve credit for this accomplishment in such a short
period of time. We believe our OAS will become an important device that allows physicians to more easily treat peripheral artery disease."

The Orbital Atherectomy Device utilizes a diamond coated, eccentrically rotating cutting surface to ablate tissue. The Company believes the resulting particles are small enough to pass through capillaries and be eliminated by the body. The Company is working on obtaining FDA clearance for use of the device in peripheral vascular disease, and approval for use in coronary arteries.

The Company has previously announced it had received marketing clearance from the U.S. Food & Drug Administration (FDA). The FDA 510(k) cleared-to-market the Company's Orbital Atherectomy System to remove tissue causing stenosis in synthetic A-V shunts. The Company expects to conduct initial market testing at a limited number of clinical sites before having a fullcommercial release of the product for treating AV shunts.

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