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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

MINNEAPOLIS, Oct. 4 /PRNewswire/ -- BridgePoint Medical, Inc., a medical device company focused on coronary and peripheral catheter-based systems for chronic total occlusion (CTO) recanalization, announced the completion of the FAST-CTOs study. BridgePoint's 16 center, 147 patient U.S. FAST-CTOs (Facilitated Antegrade Steering Technique for the treatment of Chronic Total Occlusions) study was designed to assess the safety and effectiveness of the CrossBoss and Stingray devices in chronically occluded coronary arteries.

Chad Kugler, President and General Manager of BridgePoint said, "The trial was extremely well executed by our study investigators.  Follow-up and data collection was completed for our FAST-CTOs patients in August and we filed a request for an indication expansion of our 510(k) clearance at the end of September."

The FAST-CTOs data were unveiled to the interventional community at the TCT conference in Washington, D.C., by study investigator R. Michael Wyman MD.  Wyman highlighted a 77% overall effectiveness of the BridgePoint CTO recanalization system in patients that were refractory to the current standard of care.  In addition, the data show that crossing success accelerated to 86% in the last half of the trial as investigators became more facile with the devices and associated techniques.  Wyman highlighted that the FAST-CTOs study included more difficult (longer length) total occlusions while achieving a significantly higher success rate and lower adverse event rate as compared to other CTO clinical trials.    

"In coronary CTO revascularization, operator technique and new guidewire technology have lead to modest improvement in short term antegrade success over the last decade, and drug-eluting stents have dramatically improved long-term durability. Despite these advances attempt rates remain low and the presence of a CTO remains the primary reason for referral of a patient to bypass surgery,"
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SOURCE BridgePoint Medical, Inc.
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