Cardiovascular Systems, Inc. Announces Approval For European Clinical Trial
MINNEAPOLIS, Feb. 3 /PRNewswire/ -- Cardiovascular Systems, Inc. (CSI), today announced that it has received conditional approval from the Freiburg Ethics Commission to commence a clinical study of its Orbital Atherectomy System for the treatment of peripheral vascular disease. The trial will receive unconditional approval following CSI's notification to the Commission of its German Insurance carrier.
Michael Kallok, CEO of Cardiovascular Systems, Inc. said, "We are pleased to have received Ethic Commission approval for our first human use of our device in treating peripheral vascular disease. The clinical study will include up to sixty-five patients at up to four European investigational sites. We anticipate the trial will start in Frankfurt, German in mid February."
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.
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 U.S. 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, (ii) our statement that the Company is working on obtaining FDA clearance for use of the device in peripheral vascular disease and approval for use in coronary arteries, and (iii) our statement that we will obtain unconditional approval to commence a clinical trial in Europe to treat peripheral vascular disease upon notification of the commission of our German coverage. Each of these forward- looking statements 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.
Cardiovascular Systems, Inc.CONTACT: Michael J. Kallok, Chief Executive Officer, or James Flaherty,Chief Financial Officer, of Cardiovascular Systems, Inc., +1-763-544-1890
Web site: http://www.cardiovascularsystemsinc.com/