Cordis to Distribute TriReme Medical's Chocolate PTA Balloon Catheter

February 18, 2014—Cordis Corporation (Bridgewater, NJ) announced that it has entered into an agreement with TriReme Medical Inc. (Pleasanton, CA) in which Cordis gains exclusive distribution rights for the Chocolate PTA Balloon Catheter. 

The Chocolate balloon catheter gained CE Mark in January 2011 and FDA clearance for use in the peripheral vasculature in December 2011. Cordis describes the device as being designed to allow for atraumatic dilatation, and its unique nitinol constraining structure creates uniform “pillows” that make contact with the vessel and “valleys” that allow for plaque modification and are designed to relieve stress upon inflation.

Data from the Chocolate BAR Registry studying the device were presented at the 2014 Leipzig Interventional Course (LINC). Chocolate BAR was a prospective, core lab–adjudicated registry conducted at 33 centers in the United States. The presented data included outcomes from the first 350 patients enrolled, and the company states that these results demonstrated high rates of treatment success and limb preservation. Patients enrolled in the registry were described as having advanced lower extremity atherosclerotic disease, including those at high risk of amputation (Rutherford classes 5 and 6, total occlusions, and long and calcified lesions). 

“The Chocolate PTA Balloon Catheter features a unique nitinol constraining structure design that reduces dissections by shielding the vessel wall from typical torsional stress caused by standard balloons. The result is greater safety and less recoil with excellent angiographic results in complex and calcified lesions," said Tony Das, MD, Chief of Cardiovascular Services and Director of Research and Innovation at Walnut Hill Medical Center, in Dallas, Texas, in the company's announcement. “This is an important therapy for above- and below-the knee disease currently and has the potential to serve as an excellent platform for drug elution in the future.