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BridgePoint Medical®, Inc. Completes and Submits to FDA in the U.S. FAST-CTOs With the CrossBoss® and Stingray® CTO Recanalization System
Date:10/4/2010

commented Patrick Whitlow MD, FAST-CTOs study principal investigator. "The high success rate in very long, difficult CTO cases found with the CrossBoss and Stingray in FAST-CTOs represents a major step forward and a new standard in CTO intervention. The safety of the devices and intuitive ease of use coupled with the remarkable success should expedite rapid adoption of these new devices into clinical practice."

About the PFAST-CTOs Peripheral Trial

Also today, BridgePoint announced that it received approval from the United States Food and Drug Administration (FDA) to start the PFAST-CTOs study (Peripheral Facilitated Antegrade Steering Technique for the treatment of Chronic Total Occlusions).  The 50 patient 10 center trial is intended to assess the safety and effectiveness of the BridgePoint recanalization system in lower extremity CTOs.    

About CrossBoss and Stingray

The BridgePoint CTO recanalization system used in both studies includes an over-the-wire CrossBoss Catheter delivered over standard guidewires to the site of a chronic total occlusion. The blunt tip CrossBoss Catheter utilizes the Fast-Spin technique to facilitate crossing of CTOs along true lumen or subintimal pathways.  The Stingray Catheter is an over-the-wire re-entry system allowing true lumen access from a subintimal plane.  In concert, the system allows subsequent revascularization by debulking, balloon angioplasty and stent placement. For many patients, this minimally invasive, endovascular approach to CTO recanalization may eliminate the need for invasive bypass surgery and chronic reliance on pharmacologic therapy.

About Chronic Total Occlusions

The National Heart, Lung and Blood Institute (NHLBI) estimates that Chronic Total Occlusions (CTOs) are common and are found in approximately one-third of patients who undergo angiography. Patients surviving with a coronary CTO commonly suffer from poor blood ci
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SOURCE BridgePoint Medical, Inc.
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