FDA Expands Indication for CrossBoss, Stingray to Treat CTOs


May 19, 2011
The U.S. Food and Drug Administration (FDA) expanded the indication for the CrossBoss Catheter and Stingray System to include the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to percutaneous transcatheter coronary angioplasty (PTCA) or stent intervention.

CTOs are chronically stenosed lesions that completely block a coronary artery – typically for three months or longer – and prevent blood circulation to critical areas of the heart.

This expanded indication is the result of data generated from the 147-patient FAST-CTOs clinical trial in which the safety and effectiveness of the system in coronary chronic total occlusions was demonstrated.

The FDA granted the expanded indication in May 2011.

For more information: www.bridgepointmedical.com