BridgePoint Commences Trial of CTO Devices

March 11, 2009—BridgePoint Medical, Inc. (Minneapolis, MN) announced the commencement of enrollment in a clinical investigation of the company's devices for the treatment of chronic total occlusions (CTOs). The FAST-CTOs (Facilitated Antegrade Steering Technique for Chronic Total Occlusions) study was conditionally approved by the US Food and Drug Administration in January 2009 to evaluate the safety and efficacy of the company's CrossBoss CTO catheter and Stingray CTO re-entry system.

According to the company, interventional cardiologist William Lombardi, MD, completed the first clinical case in which the patient was a woman aged 61 years with a CTO of her right coronary artery, chest pain (characterized as level three angina), and a positive stress test. The patient was referred to Dr. Lombardi for inclusion in BridgePoint Medical's FAST-CTOs clinical trial after a failed treatment attempt to cross the lesion by the referring physician. Dr. Lombardi is director of the cardiac catheterization lab at North Cascade Cardiology, in Bellingham, Washington. Procedural completion took 35 minutes, resulting in the opening of the completely blocked vessel and return of normal blood flow to the patient's heart. The patient was released from the hospital the day after the procedure.