FlowCardia, Inc. Initiates CENTRAL Study Enrollment - Gilde Healthcare

FlowCardia, Inc. Initiates CENTRAL Study Enrollment

9 February 2010

Study designed to confirm CROSSER® Catheter routinely navigates through the central lumen of SFA chronic total occlusions

Sunnyvale, CA – FlowCardia, Inc., a worldwide leader in the development of endovascular devices for the treatment of chronic total occlusions (CTOs), today announced Dr. John Paul Runyon from The Christ Hospital in Cincinnati, Ohio successfully enrolled the first patient into the CENTRAL (Crosser ENters The Right Arterial Lumen) study.

“The acute benefits of staying within the central lumen and not causing trauma to the artery wall are well documented and we are excited to be involved in this study.”

said Dr. John Paul Runyon, an interventional cardiologist at The Christ Hospital in Cincinnati, OH.

“Most treatment options for peripheral artery disease require staying in the central lumen to be most effective. Using the CROSSER Catheter as a front line therapy allows us to use further treatment options resulting in increased long term benefits to the patient.”

The 8 hospital, 100 patient CENTRAL study is designed as a single arm registry that involves recanalizing the occlusion and demonstrating successful navigation of the CROSSER Catheter in the central lumen of the artery as confirmed by Intravascular Ultrasound (IVUS). Also noted in the study, will be the Re-Entry Ratio or utilization rate of lumen re-entry devices during CTO recanalization procedures. When CTO’s are crossed within the central lumen of the artery, the need for these re-entry devices is dramatically reduced.

“This unique study will validate the CROSSER Catheter’s ability to provide treatment while staying within the central lumen of the artery to a greater degree than the currently available recanalization devices and techniques,

said national principal investigator of the CENTRAL study, Dr. Tom Davis of St. John Hospital and Medical Center in Detroit, MI.

 
The CROSSER CTO Recanalization Catheter is a minimally-invasive endovascular device that is delivered to the blockage within the artery using standard guidewire techniques. The doctor then activates the CROSSER Catheter which utilizes high-frequency, mechanical vibration to pass through the blockage in the central lumen of the artery. Once the CROSSER Catheter passes through the occlusion, physicians can then perform standard procedures to optimize the longer term outcomes.
 
FlowCardia, Inc. is a privately held medical device company established in 2002 to design and manufacture a portfolio of endovascular CTO recanalization products. Additional information is available on the company’s web site at: www.flowcardia.com.

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