Orbital Atherectomy System for the Treatment of Peripheral Artery Disease
Apr 12, 2005 - 3:24:00 PM
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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.
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By Cardiovascular Systems, Inc,
[RxPG] 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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Additional information about the news article
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Cardiovascular Systems, Inc. is a medical device development company that has completed design, development, and testing of its Orbital Atherectomy Device intended for removal of atherosclerotic blockages in coronary and peripheral arteries. The Company's proprietary technology is protected by 22 issued US patents and several other pending patents.
Cautionary Statement for the Purpose of the "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including (i) our statement that we expect to conduct initial market testing of our product for treating AV Shunts at a limited number of clinical sites before a full commercial release. This forward-looking statement is based upon current expectations and beliefs and is subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in or anticipated by the forward-looking statements. For example, the full commercial release of our product for treating AV Shunts is subject to our obtaining satisfactory results from our initial market tests and the development of manufacturing and marketing capabilities. There is no assurance that we will be successful in these undertakings. In addition, our ability to obtain approvals from the FDA and European regulatory bodies depends upon the successful performance of our product in testing and the submission to the FDA or other regulatory bodies of appropriate evidence of such performance. We may encounter problems in testing or regulatory review that delay or prevent us from obtaining such approvals.
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