The first patient of the PATRIOT (Peripheral Approach To Recanalization In Occluded Totals) U.S. pivotal study has been enrolled by Dr. Naveen Sachdev from Providence St. Vincent's Hospital in Portland, Oregon. The study is designed to determine the safety and efficacy of the CROSSER 14 and CROSSER 18 Catheters by FlowCardia for CTO recanalization in the upper and lower legs.
The CROSSER System is a monorail catheter delivered over standard .014" and .018" guide wires to the site of a CTO. The CROSSER utilizes high frequency vibration to quickly cross CTOs allowing for subsequent plaque debulking, balloon angioplasty and stent placement.
Additionally, FlowCardia has announced FDA 501(k) submission for the CROSSER 14 coronary platform.
FlowCardia, Inc., a medical device company focused on catheter-based devices for coronary and peripheral chronic total occlusion (CTO) recanalization,
For further information www.flowcardia.com