BridgePoint Medical, a developer of new technologies and techniques to treat coronary and peripheral artery disease, has received an expanded indication for the CrossBoss Catheter and Stingray System from the the US Food and Drug Administration (FDA) to treat coronary chronic total occlusion (CTO).
The expanded indication includes the intraluminal placement of conventional guidewires beyond stenotic coronary lesions [including CTO] prior to PTCA or stent intervention.
The 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.
BridgePoint Medical CEO and president Denis Harrington said the FAST-CTO Trial demonstrated the safety and effectiveness of the CrossBoss Catheter and Stingray System in treating CTOs.