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FlowCardia, Inc. Announces 510(k) Clearance For The CROSSER(TM) 14 Chronic Total Occlusion Recanalization System



1/23/2007 9:47:56 AM

SUNNYVALE, Calif., Jan. 23 /PRNewswire/ -- FlowCardia, Inc., a medical device company developing endovascular devices for coronary and peripheral chronic total occlusion (CTO) recanalization, announced FDA 510(k) clearance of the CROSSER(TM) 14 CTO Recanalization System. The CROSSER 14 is designed to facilitate the placement of guidewires beyond CTOs in coronary arteries.

The CROSSER 14 is an endovascular catheter that is delivered using standard guidewires to the site of a chronic total occlusion in the coronary arteries. The CROSSER utilizes high-frequency vibration to facilitate guidewire crossing of CTOs allowing for subsequent balloon angioplasty and stent placement. For many patients, this cath-lab based, minimally invasive approach to CTO recanalization can eliminate the need for potentially traumatic Coronary Artery Bypass Graft (CABG) surgery.

The CROSSER 14 clearance follows the completion of the U.S. FACTOR (FlowCardia's Approach to Chronic Total Occlusion Recanalization) clinical study. FlowCardia's 19 hospital, 125 patient pivotal study successfully assessed the safety and efficacy of the CROSSER Catheter in chronically occluded coronary arteries.

Wick Goodspeed, President and CEO of FlowCardia said, "The CROSSER 14 Catheter represents a major milestone for FlowCardia in the U.S. market. With more coronary and peripheral devices in the immediate pipeline, we hope to give all CTO patients a safe and effective, minimally invasive, therapeutic option."

FlowCardia, Inc. is a privately held medical device company established in 2002 to design and manufacture safe and effective, endovascular CTO recanalization systems. Additional information is available on the Company's new Web Site at www.flowcardia.com.

CONTACT: Mark Page Director, Marketing FlowCardia, Inc. 408-617-0352 ext. 301

Source: FlowCardia, Inc.

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