Abbott receives US regulatory clearance and Japanese approval for TREK Coronary Dilatation Catheters

Abbott (NYSE: ABT) today announced 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 is used in angioplasty procedures and is designed to enable interventional cardiologists to open patients' narrowed coronary arteries. The TREK system received CE Mark and was launched in Europe in May 2010.

"Balloon dilatation catheters help physicians open up, or pre-dilate, a lesion before a stent is placed – a step which has been shown to improve patient outcomes when the stent is later expanded in the vessel," said David Rizik, M.D., medical director of invasive cardiology at Scottsdale Healthcare Shea Medical Center. "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."

"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," said Etsuo Tsuchikane, M.D., co-director of cardiovascular medicine at the Toyohashi Heart Center in Japan. "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."

The TREK family of balloon catheters incorporates several design and technology changes that have the potential to improve deliverability and performance. TREK RX is available in Japan, and both TREK RX and TREK OTW are available in the United States. The TREK system is available in two catheter designs, including the specialty catheter MINI-TREK (available in the U.S. in 1.50 to 2.0 mm sizes and available in Japan in 1.20 to 2.0 mm sizes) for accessing smaller vessels. TREK is available in more than 70 sizes and in a wide variety of diameters (from 1.2 mm to 5 mm) and lengths (from 6 mm to 30 mm).

"The TREK system is another example of Abbott delivering innovative technologies from its broad vascular pipeline," said Robert Hance, senior vice president, vascular, Abbott. "Abbott is focused on building its leadership in balloon dilatation catheters, and we believe the advanced design of the TREK balloon dilatation catheter will meet physicians' needs and has the potential to improve patient outcomes. With today's announcement, TREK is now available in all major markets and further enhances the comprehensive portfolio of tools that we offer to physicians to treat their patients with coronary artery disease."