MINNEAPOLIS, Feb. 3 /PRNewswire/ -- Cardiovascular Systems, Inc. (CSI), today announced that it has 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.
Michael Kallok, CEO of Cardiovascular Systems, Inc. said, “We are very pleased to announce the first clearance for our Orbital Atherectomy System. Our device will provide physicians with a method for removing occlusive tissue in synthetic AV shunts used for vascular access in hemodialysis patients. 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 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 shunts.
Kallok added, “The Company is working on obtaining FDA clearance for use of the device in peripheral vascular disease, and approval for use in coronary arteries. In addition, the Company is currently awaiting approval to commence a clinical trial in Europe to treat peripheral vascular disease.”
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 are awaiting approval to commence a clinical trial in Europe to treat peripheral vascular disease. 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/