Jan. 23, 2007 — The FDA has granted 510(k) clearance for FlowCardia’s CROSSER 14 CTO Recannalization System, an endovascular catheter designed to help place standard guide wires beyond chronic total occlusions in coronary arteries.
Deployed during a minimally invasive procedure in the cath lab, the CROSSER uses high-frequency vibration to advance a guide wire across CTOs, enabling balloon angioplasty and stent placement and thus averting CABG surgery for many patients.
The clearance follows completion of the U.S. FACTOR (FlowCardia's Approach to Chronic Total Occlusion Recanalization) clinical study. FlowCardia's 19-hospital, 125-patient pivotal study successfully assessed the safety and efficacy of the CROSSER Catheter in chronically occluded coronary arteries.
For more information about CROSSER, visit www.flowcardia.com