Healthcare Industry News:  Critical Limb Ischemia 

Devices Interventional FDA

 News Release - September 18, 2006

FDA Approves Center Expansion of Cardiovascular Systems, Inc. Clinical Trial of the Orbital Atherectomy System

ST. PAUL, Minn., Sept. 18 (HSMN NewsFeed) -- Cardiovascular Systems, Inc. (CSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the expansion of the OASIS clinical trial from ten to 20 centers. The OASIS trial, sponsored by CSI, is being conducted to gather safety and effectiveness data on the Orbital Atherectomy System (OAS). OAS is a catheter-based system that uses a diamond coated crown to remove plaque from peripheral arteries. The novel design of the OAS allows the crown to create a final lumen about twice the size of the crown.

Michael J. Kallok, PhD, CSI's Chief Executive Officer said, "We are pleased with the FDA's approval allowing us to expand the OASIS trial with ten additional centers. With 20 active sites we will be able to continue the pivotal trial at more centers and with more physicians. We expect this will improve our ability to evaluate the Orbital Atherectomy System and help validate its safety and effectiveness for treatment of PAD."

Over 12 million people in the US alone suffer from PAD which can cause debilitating pain in the legs. If allowed to progress, PAD can lead to Critical Limb Ischemia which may result in amputation of the leg if not treated. It is estimated that less than two million people are actually diagnosed with PAD and less than 700,000 are treated therapeutically each year.

About CSI

Cardiovascular Systems, Inc. is an early stage medical device 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 over 20 issued US patents and corresponding foreign patents, and several other pending patents. The Company has received 510(k) clearance to market its Orbital Atherectomy System for treatment of occluded AV Grafts used for hemodialysis access and has obtained CE mark for peripheral vascular use.

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 statement that the Company is working on obtaining FDA approval of its IDE for use of the Orbital Atherectomy System for treating blocked peripheral arteries. The 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, our ability to obtain approvals from the FDA 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.

Source: Cardiovascular Systems

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