SUNNYVALE, Calif., Dec. 11 /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 FDA 510(k) clearance and immediate U.S. launch of the CROSSER 14P, CROSSER 14S and CROSSER 18 CTO Recanalization Catheters.
The three peripheral CROSSER Catheters are endovascular tools used by interventional radiologists, vascular surgeons and interventional cardiologists to cross CTOs to help restore blood flow to the lower legs. The CROSSER is a rapid exchange catheter delivered over standard .014" and .018" guidewires that utilizes high frequency vibration to cross CTOs allowing for subsequent debulking, balloon angioplasty and stent placement. The peripheral CROSSER Catheters were studied in the FlowCardia PATRIOT Trial.
The PATRIOT Study principle investigator, Dr. Jim Joye, commented, "After completing the clinical trial, we are looking forward to using the CROSSER in our daily practice. The device worked well in the upper leg and also proved an excellent primary therapy for 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."
Chris Barys, Sr. Vice President of Sales said, "We are aggressively assembling our sales organization and we look forward to offering a complete, peripheral portfolio of catheters to our interventional customers. Having three CROSSER Catheter models available for use in the peripheral vasculature will allow physicians to choose the appropriate catheter based on vessel size and CTO location. This approval is significant and a true win for patients all over the world."
FlowCardia, Inc. is a privately held medical device company established in 2002 to design and manufacture a safe and effective portfolio of CTO recanalization products. Additional information is available on the Company's Web Site at http://www.flowcardia.com.
CONTACT: Mark Page, Sr. Director, Worldwide Marketing of FlowCardia, Inc.,
Web site: http://www.flowcardia.com/