From rxpgnews.com
Orbital Atherectomy System for the Treatment of Peripheral Artery Disease
By Cardiovascular Systems, Inc,
Apr 12, 2005 - 3:23:38 PM
Cardiovascular Systems, Inc. (CSI), today announced that the first twelve patients have been enrolled in the European Clinical Trial of its Orbital Atherectomy System for the treatment of peripheral artery disease. The first-ever use of the device in patients was performed by Horst Sievert, MD, Director of the CardioVascular Center, Sankt Katharinen Hospital, Frankfurt Germany on March 29. Thomas Zeller, MD, Herz-Zentrum, Bad Krozingen, Germany began treating patients the week of April 4.
All patients had successful debulking of their lesions with no acute adverse events. The trial will continue to enroll up to sixty five patients at up to four centers.
Michael Kallok, CEO of Cardiovascular Systems, Inc., said, "We are pleased that our device was used successfully to treat these first patients in Frankfurt and Bad Krozingen. We are grateful to Professor Sievert and Dr. Zeller for their excellent clinical and technical skills to help CSI evaluate its Orbital Atherectomy System for treatment of peripheral artery disease. We look forward to continuing patient enrollment in this European safety study."
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 full commercial release of the product for treating AV shunt.
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