Healthcare Industry News:  FlowCardia 

Devices Interventional

 News Release - June 27, 2006

FlowCardia, Inc. Completes Enrollment in PATRIOT Peripheral Feasibility Study With the CROSSER CTO Recanalization System

SUNNYVALE, Calif., June 27 (HSMN NewsFeed) -- FlowCardia, Inc., a medical device company focused on catheter-based systems for the recanalization of coronary and peripheral chronic total occlusions (CTO), announced the completion of enrollment into the PATRIOT feasibility study. FlowCardia's 4 hospital, 40 patient U.S. PATRIOT (Peripheral Approach To Recanalization In Occluded Totals) Feasibility Study was designed to assess the safety and efficacy of FlowCardia's CROSSER Catheter in totally occluded peripheral arteries.

The CROSSER(TM) System is a monorail catheter delivered over standard .014" and .018" guidewires to the site of a chronic total occlusion. The CROSSER utilizes high frequency, mechanical vibration and is designed to quickly cross CTO's 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 or amputation.

Dr. Jim Joye, the PATRIOT Study principle investigator commented, "The success we have seen with the CROSSER in the Patriot Trial to this point have been very encouraging. The device is safe and effective at traversing even the more difficult appearing occlusions below the knee. The addition of this tool will assist physicians in approaching lesions that previously could only be treated with a more invasive open surgery."

Wick Goodspeed, President and CEO of FlowCardia said, "The CROSSER 14 system was utilized in 95% of the PATRIOT cases. With the majority of the study occlusions presenting above the knee, we were very pleased with the CROSSER success rate. We are even more excited about our new CROSSER 18 which was designed for above the knee applications and used in the final PATRIOT cases. The CROSSER 18 should allow us to demonstrate a dramatic improvement in crossing total occlusions in the SFA."

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 Web Site at www.FlowCardia.com.


Source: FlowCardia

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