BridgePoint seeks FDA approval for CTO recanalization system

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BridgePoint Medical submitted to the FDA the results of its U.S. FAST-CTO (Faciliated Antegrade Steering Technique for the treatment of Chronic Total Occlusions) clinical trial, which studied the safety and effectiveness of the CTO recanalization system that includes the CrossBoss catheter and Stingray device in 147 patients.

The results of the trial, presented at the 2010 Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C. in late September, showed that there was a 77 percent success rate when the BridgePoint device was used in chronically occluded coronary arteries, which increased to 86 percent at the last half of the trial.

The Minneapolis-based company said that the FDA has granted approval for the company to begin its PFAST-CTO (Peripheral Facilitated Antegrade Steering Technique for the treatment of Chronic Total Occlusions) study that will enroll 50 patients at 10 centers and assess the safety of the BridgePoint system in lower extremity CTOs.