BridgePoint Medical Announces US IDE Approval and First Patient Enrollment of Peripheral Chronic Total Occlusion Study
Published: Aug 03, 2011
MINNEAPOLIS, Aug. 3, 2011 /PRNewswire/ -- BridgePoint Medical, Inc., a Minnesota-based medical device company, has announced that they have enrolled their first patient in the Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions (PFAST-CTOs) study. The company received approval from the FDA in July, 2011 to move forward with the US based IDE for the peripheral devices and is now actively enrolling patients. The 10 center, 100 patient U.S. PFAST-CTOs study is designed to assess the safety and effectiveness of the BridgePoint devices in chronically occluded arteries located in the lower extremities.
Dr. Subhash Banerjee of the VA North Texas Health Care System and UT Southwestern Medical Center, the first physician to enroll a patient in the PFAST-CTOs study, stated, "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."
The BridgePoint peripheral products are similar to the coronary system in concept, but have been specifically designed and adapted for use in peripheral vasculature and will expand the company's reach into the fast growing peripheral market.
Company CEO and President Denis Harrington reflected, "This is a very important milestone for BridgePoint Medical. With the IDE approval and the first case enrolled, we are now officially started in our quest to build a strong Peripheral CTO franchise to complement our market leading Coronary CTO franchise."
About Peripheral Artery Disease and Chronic Total Occlusions:
Atherosclerotic peripheral artery disease (PAD) is a widely prevalent disorder that affects millions world-wide and is associated with significant morbidity and mortality. A CTO, which represents a complete artery blockage, typically cannot be treated with standard endovascular interventional devices and is often treated with surgery or medical therapy. 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. Various studies have estimated that Chronic Total Occlusions (CTOs) are common and are found in approximately 50% of patients who undergo angiography.
About BridgePoint Medical:
BridgePoint Medical, Inc. is a privately held company established in 2006 to design, develop and commercialize new technologies and techniques to treat challenging coronary and peripheral artery disease. Investors include New Enterprise Associates, Polaris Venture Partners, Foundation Medical Partners and Michael Berman.
SOURCE BridgePoint Medical, Inc.