BridgePoint's CrossBoss and Stingray Clearance Expanded to Treat CTOs

May 16, 2011—BridgePoint Medical, Inc. (Plymouth, MN) announced that the company has received US Food and Drug Administration (FDA) clearance for an expanded indication for the CrossBoss catheter and Stingray system. The expanded indication includes the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) before percutaneous transluminal coronary angioplasty or stent intervention.

According to the company, the expanded FDA indication is the result of data generated from the 147-patient FAST-CTOs (Facilitated Antegrade Steering Technique in Chronic Total Occlusion) clinical trial in which the safety and effectiveness of the system in coronary CTOs was demonstrated.

“The BridgePoint system is the first set of devices designed specifically for treating coronary CTOs that has shown real improvements in safety, procedural efficiency, and clinical success rates,” commented investigator William Lombardi, MD. “The clinical trial has proven that these arteries can be opened effectively with these products, and now with the expanded indication from the FDA, there will be a new level of awareness among physicians and patients.”