BridgePoint Medical, a medical device company focused on coronary and peripheral catheter-based systems for chronic total occlusion (CTO) recanalisation, has completed the FAST-CTOs (Facilitated Antegrade Steering Technique for the treatment of Chronic Total Occlusions) study.
The FAST-CTOs was designed to assess the safety and effectiveness of the CrossBoss and Stingray devices in chronically occluded coronary arteries.
BridgePoint president and general manager Chad Kugler said that the trial was extremely well executed by their study investigators and follow-up and data collection was completed for FAST-CTOs patients in August and they filed a request for an indication expansion of 510(k) clearance at the end of September.
Michael Wyman has presented the study data at the TCT conference in Washington DC, demonstrating 77% overall effectiveness of the BridgePoint CTO recanalization system in patients that were refractory to the current standard of care.
In addition, the data showed that crossing success accelerated to 86% in the last half of the trial as investigators became more facile with the devices and associated techniques.
BridgePoint has also received approval from the US Food and Drug Administration to start the PFAST-CTOs study (Peripheral Facilitated Antegrade Steering Technique for the treatment of Chronic Total Occlusions), which is intended to assess the safety and effectiveness of the BridgePoint recanalization system in lower extremity CTOs.