SUNNYVALE, Calif., Sept. 12 /PRNewswire/ -- 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 pivotal study. FlowCardia's 8 hospital, 85 patient U.S. PATRIOT (Peripheral Approach To Recanalization In Occluded Totals) Study was designed to assess the safety and efficacy of the peripheral line of CROSSER Catheters in lower limb CTOs.
The CROSSER(TM) is a rapid exchange catheter delivered over standard .014" and .018" guidewires to the site of a CTO. Utilizing high frequency vibration, the CROSSER Catheter is designed to safely and quickly cross CTOs allowing for subsequent debulking, balloon angioplasty and stent placement. The CROSSER(TM) 14P, CROSSER(TM) 14S and CROSSER(TM) 18 Catheters were studied in the PATRIOT Trial.
Dr. Jim Joye, the PATRIOT Study principle investigator commented, "We were very pleased with the success of the CROSSER in the PATRIOT Study. 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."
"We are very pleased with the results from the PATRIOT Study," said Wick Goodspeed, President and CEO of FlowCardia. "Having 3 CROSSER Catheter models for use in the study allowed physicians to choose the appropriate Catheter based on vessel size and CTO location. The CROSSER family delivered a simple, safe and effective solution for crossing CTOs in the legs."
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 http://www.flowcardia.com.
CONTACT: Mark Page
Sr. Director, Worldwide Marketing & International Sales
CONTACT: Mark Page, Sr. Director, Worldwide Marketing & InternationalSales of FlowCardia, Inc., +1-408-617-0352