Healthcare Industry News: Guidewire
News Release - November 2, 2006
FlowCardia, Inc. Initiates PATRIOT Pivotal Study Enrollment and Announces Coronary FDA 510(k) Submission for CROSSER(TM) Catheter System
SUNNYVALE, Calif., Nov. 2 (HSMN NewsFeed) -- FlowCardia, Inc., a medical device company focused on catheter-based devices for coronary and peripheral chronic total occlusion (CTO) recanalization, announced Dr. Naveen Sachdev from Providence St. Vincent's Hospital in Portland, Oregon, successfully enrolled the first patient into the PATRIOT study. 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 14 and CROSSER 18 Catheters for CTO recanalization in the upper and lower legs.The CROSSER(TM) System is a monorail catheter delivered over standard .014" and .018" Guidewires to the site of a CTO. The CROSSER utilizes high frequency vibration to quickly cross CTOs allowing for subsequent plaque debulking, balloon angioplasty and stent placement. For many patients with chronic occlusions in the legs, this minimally invasive, endovascular approach to CTO recanalization will eliminate the need for potentially traumatic bypass surgery or amputation.
FlowCardia also announced FDA 501(k) submission for the CROSSER 14 coronary platform. The data used to support the coronary submission came from FlowCardia's 19 hospital, 125 patient U.S. FACTOR (FlowCardia's Approach to Chronic Total Occlusion Recanalization) pivotal study. The FACTOR Study was designed to assess the safety and efficacy of the CROSSER Catheter for chronically occluded coronary artery recanalization.
Wick Goodspeed, President and CEO of FlowCardia said, "With our 510(k) submission filed with the FDA, we anticipate receiving coronary clearance for the CROSSER 14 Catheter by the end of this year."
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.
Source: FlowCardia
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