BridgePoint Medical Earns CE Mark Approval for Stingray and CrossBoss CTO Devices

November 23, 2009—BridgePoint Medical, Inc. (Minneapolis, MN) announced that it received CE Mark approval for its coronary and peripheral chronic total occlusion (CTO) crossing system composed of the CrossBoss CTO crossing catheter and the Stingray CTO re-entry system. The BridgePoint system is a series of disposable interventional catheters that are designed to navigate highly diseased arteries in preparation for blood flow restoration via angioplasty and stenting.

The BridgePoint Medical CrossBoss and Stingray are indicated in the European Union for adults (age 18 and older) with coronary or peripheral artery disease. The devices are contraindicated for use in cerebral vasculature, the company advised. In the United States, the devices are currently under clinical investigation and are not commercially available for treating CTOs.

According to the company, in a prospective clinical trial conducted in the European Union and a postmarket registry conducted primarily in South America, the BridgePoint System was 67% to 85% successful in placing an interventional guidewire beyond a coronary CTO. Complications with the system were similar to general percutaneous coronary intervention and stenting.

“This system is the first to provide a new option for the frequent situation when our guidewires do not reach the vessel beyond the occlusion,” commented Gerald Werner, MD, PhD. “The BridgePoint system makes it possible to find the true vessel lumen and conclude the treatment successfully.”