MINNEAPOLIS, Feb. 23 /PRNewswire/ -- Cardiovascular Systems, Inc. (CSI), today announced that it has received recommendation for ISO 13485:2003 registration of its quality management system. The recommendation was issued following an initial quality management system assessment visit by our notified body BSI, Inc. This recommendation represents an important step towards receiving authorization to affix the CE Mark of conformity, allowing European commercialization.
Michael J. Kallok, CEO of Cardiovascular Systems, Inc. said, “We are pleased to announce that our quality management system has been recommended for ISO quality system registration. Our product development and manufacturing teams deserve credit for this accomplishment in such a short period of time.”
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 shunts.
Cardiovascular Systems, Inc. is a medical device development company which has designed, developed, and is testing its Orbital Atherectomy Device 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 our statements that i) 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 ii) the Company intends a full commercial release of our product for treating AV shunts. 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, +1-763-544-1890, both of Cardiovascular Systems,Inc.
Web site: http://www.cardiovascularsystemsinc.com/