News | February 28, 2014

Cordis, TriReme Enter Distribution Agreement for Chocolate PTA Balloon Catheter

Cordis Trieme Chocolate PTA Balloon Catheter Peripheral Artery Disease PAD

February 28, 2014 — Cordis Corp. announced an agreement with TriReme Medical Inc. that grants the company exclusive distribution rights for the Chocolate PTA Balloon Catheter. 

The Chocolate PTA Balloon Catheter, approved in the United States in December 2011, is a PTA balloon that is designed to allow for atraumatic dilatation in treating peripheral artery disease (PAD). The Chocolate PTA Balloon Catheter is indicated for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries. 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.

It is estimated that approximately 27 million people in Western Europe and North America have peripheral arterial disease (PAD), which is associated with significant morbidity and mortality.

“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, M.D., chief of cardiovascular services and director of research and innovation at Walnut Hill Medical Center, Dallas, Texas. 

Data from the Chocolate BAR Registry, a prospective, core lab-adjudicated registry conducted at 33 U.S. clinical centers, was presented at the 2014 Leipzig Interventional Course (LINC) by Das, who is an investigator of the study. Results on the first 350 patients enrolled in the registry treated with the Chocolate PTA Balloon Catheter demonstrated high rates of treatment success and limb preservation. Patients enrolled in the registry had advanced atherosclerotic disease in their legs and included patients at high risk of amputation (Rutherford 5 and 6, total occlusions, long and calcified lesions).

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