FlowCardia Finalizes Enrollment in Catheter Study in CTOs
September 12, 2007 - FlowCardia Inc., a medical device company developing a portfolio of endovascular devices for the treatment of coronary and peripheral chronic total occlusions (CTOs), announced the completion of enrollment into the PATRIOT study (Peripheral Approach To Recanalization In Occluded Totals), which is designed to assess the safety and efficacy of the peripheral line of CROSSER Catheters in lower limb CTOs.
FlowCardia’s study includes eight hospitals and 85 patients. The CROSSER is a rapid exchange catheter delivered over standard .014-in and .018-in guidewires to the site of a CTO. Utilizing high frequency vibration, the CROSSER Catheter is designed to cross CTOs allowing for subsequent debulking, balloon angioplasty and stent placement. The CROSSER 14P, CROSSER 14S and CROSSER 18 Catheters were studied in the PATRIOT Trial.
"The device worked well in the upper leg and also proved safe and effective crossing the more difficult, below the knee occlusions. This new endovascular line of catheters will help us cross lesions that previously could only be treated with a more invasive open surgery," said Dr. Jim Joye, M.D., the PATRIOT Study principle investigator.
For more information: www.flowcardia.com