BridgePoint Medical Completes and Submits to FDA in the U.S. FAST-CTOs With the CrossBoss(R) and Stingray(R) CTO Recanalization System
10/5/2010 7:15:50 AM
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," 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 circulation to the heart muscle that induces symptoms such as chest pain (angina), shortness of breath and fatigue. Studies also show that the patients living with an untreated coronary CTO are at higher risk of death. Patients with lower extremity CTOs often suffer from poor circulation in the legs often resulting in debilitating leg pain (claudication), limb threatening ischemia, and limb amputation.
About BridgePoint Medical
BridgePoint Medical, Inc. is a privately held company established in 2006 to design, develop and commercialize new technologies to treat challenging coronary and peripheral artery disease. Investors include New Enterprise Associates, Polaris Venture Partners, Foundation Medical Partners and Michael Berman. Additional information is available on the company's website at www.bridgepointmedical.com.
SOURCE BridgePoint Medical, Inc.