Healthcare Industry News: drug-eluting stent
News Release - August 8, 2006
FlowCardia, Inc. Completes Enrollment in the FACTOR Coronary Pivotal Study and Initiates the PATRIOT Peripheral Pivotal Study With the CROSSER(TM) CTO Recanalization SystemSUNNYVALE, Calif., Aug. 8 (HSMN NewsFeed) -- FlowCardia, Inc., a medical device company focused on coronary and peripheral catheter-based systems for chronic total occlusion (CTO) recanalization, announced they have completed enrollment in the FACTOR pivotal study. FlowCardia's 19 hospital, 125 patient U.S. FACTOR (FlowCardia's Approach to Chronic Total Occlusion Recanalization) pivotal study was designed to assess the safety and efficacy of the CROSSER Catheter in chronically occluded coronary arteries.
Wick Goodspeed, President and CEO of FlowCardia said, "With only 30 day clinical follow-up required for our FACTOR patients, we hope to file a request for CROSSER 510(k) clearance in September. At this point, we anticipate clearance from FDA before the end of this year."
Dr. Louis Cannon, the FACTOR Study principal investigator commented, "Although more CTO patients are being treated through the interventional approach due to advances in guidewire technology, the interventionalists are still looking for a safe, effective and simple device to recanalize chronic total occlusions. There is an unacceptable gap between the patients who present with a CTO and the patients who actually receive interventional treatment. The CROSSER, along with excellent long-term drug-eluting stent data, should give the interventional community strong rationale to treat CTOs through their minimally invasive approach."
Also today, FlowCardia announced that it received approval from the United States Food and Drug Administration (FDA) to start the pivotal phase of the PATRIOT study after completion of the feasibility phase in June of this year. FlowCardia's 10 hospital, 85 patient PATRIOT (Peripheral Approach To Recanalization In Occluded Totals) U.S. pivotal study is designed to determine the safety and efficacy of the CROSSER Catheter in totally occluded peripheral arteries.
The CROSSER System is a monorail catheter delivered over standard guidewires to the site of a chronic total occlusion. The CROSSER utilizes high frequency, mechanical vibration and is designed to facilitate crossing of CTOs allowing for subsequent debulking, balloon angioplasty and stent placement. For many patients, this minimally invasive, endovascular approach to CTO recanalization may eliminate the need for potentially traumatic bypass surgery.
FlowCardia, Inc. is a privately held medical device company established in 2002 to design and manufacture a safe and effective CTO recanalization system. Additional information is available on the Company's new Web Site at www.flowcardia.com .
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