On 3 August 2011, BridgePoint Medical announced commencement of the company’s PFAST-CTOs (Peripheral facilitated antegrade steering technique in chronic total occlusions) study. Subhash Banerjee enrolled the first patient in the study.
The company received approval for an investigational device exemption from the FDA for this study of its peripheral devices.
PFAST-CTOs will be composed of 100 patients enrolled at 10 centres in the United States. The study is designed to assess the safety and effectiveness of the BridgePoint devices in chronically occluded arteries located in the lower extremities. William A Gray is the study’s principal investigator.
According to the company, the BridgePoint peripheral products are similar in concept to the company’s coronary systems but have been specifically designed and adapted for use in the peripheral vasculature. In May 2011, the company’s CrossBoss and Stingray coronary systems received clearance from the FDA for an expanded indication that included treatment of coronary chronic total occlusions. On November 2009, the company announced that it received CE mark approval for both the coronary and peripheral systems.
“Predicated by the success of the BridgePoint coronary CTO system, we are very optimistic about the peripheral device’s performance possibilities, and we are looking forward to a robust and successful study,” commented Banerjee.