Healthcare Industry News: hemodialysis
News Release - July 19, 2006
FDA Approves Expansion of Cardiovascular Systems Inc. Clinical Trial of the Orbital Atherectomy System for Treatment of Peripheral Vascular Stenosis (OASIS)ST. PAUL, Minn., July 19 (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 following review of the safety data from the feasibility phase of the study. 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, "OASIS is the first prospective multi center clinical trial for an atherectomy device treating Peripheral Arterial Disease (PAD). We are excited to expand the OASIS trial to new centers and begin the process of enrolling the remaining patients. CSI is committed to putting clinical rigor in the data we collect during the OASIS trial as well as other trials we have planned for the future."
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.
Dr. Richard R. Heuser, of Phoenix Heart Center and Co-Principal Investigator of OASIS said, "We are excited about the eventual availability of this new therapy for the 12 million US sufferers of PAD. The OAS shows great potential and the expansion of the OASIS trial will give us the data physicians need to make informed decisions on treatment alternatives."
The first US patient was treated in January of this year by Dr. Robert D. Safian, Co-Principal Investigator of OASIS, at William Beaumont Hospital in Royal Oak, Michigan. As stated by Dr Safian, "The initial experience with orbital atherectomy has been extremely positive. The setup and utilization of the device have been very straightforward and simple. The technology can be easily incorporated into interventional practice after a very brief learning curve. The initial results are characterized by excellent angiographic appearance, excellent lumen enlargement, and lack of device-related complications, which is especially notable in this patient population with advanced peripheral arterial disease and high incidence of critical limb ischemia."
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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