Abbott's Trek Coronary Balloon System Cleared in US, Approved in Japan

January 31, 2011—Abbott Vascular (Santa Clara, CA) announced that it has received regulatory clearance in the United States and approval in Japan for its Trek and Mini-Trek coronary dilatation catheters for the treatment of coronary artery disease. The Trek system received CE Mark and was launched in Europe in May 2010.

According to the company, the Trek family of balloon catheters incorporates several design and technology changes that have the potential to improve deliverability and performance. The Trek system is available in two catheter designs, including the specialty catheter Mini-Trek for accessing smaller vessels. Mini-Trek is available in the United States in 1.5- to 2-mm sizes and in Japan in 1.2- to 2-mm sizes. Trek is available in more than 70 sizes with a variety of diameters (1.2–5 mm) and lengths (6–30 mm). Trek RX and Trek OTW are available in the United States, Trek RX is available in Japan.

“The TREK system was designed to help physicians treat a broad range of patients with tortuous anatomy, with the goal of addressing complex lesions in narrowed and difficult-to-dilate vessels,” commented David Rizik, MD.

Etsuo Tsuchikane, MD, added, “It can take multiple attempts to find the right catheter that is flexible enough to travel through twisting blood vessels and streamlined enough to push through calcified lesions, which can lead to prolonged procedure times. The Trek balloon is designed to allow physicians to more easily and accurately place the balloon, restore blood flow, and quickly bring relief to the patient.”