Cordis Negotiates Distribution Agreement with TriReme Medical for PTA Balloon Catheter

Cordis Corporation has entered into an agreement with TriReme Medical Inc. that grants the company exclusive distribution rights for the Chocolate PTA Balloon Catheter.

Cordis’ addition of the Chocolate Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter complements and expands its existing portfolio of high-performance lower extremity products, including the S.M.A.R.T. line of self-expanding stents, percutaneous transluminal angioplasty balloon catheters, and chronic total occlusion devices.

“Cordis is pleased to have the opportunity to partner with TriReme Medical on this technology,” said Celine Martin, worldwide president, Cordis Corporation. “This agreement represents our continuing commitment to identifying optimal solutions for patients suffering from peripheral artery disease.”

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.¹ Its 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.

“The Chocolate PTA Balloon Catheter features a 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. “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.”

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) earlier this month by Das, 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).

PAD is caused by the build-up of fatty substances that collect and adhere to the linings of the arteries, in a process known as atherosclerosis. The build-up causes the internal lining of the artery to thicken, narrowing the artery and limiting blood flow to vital tissues and organs. Commonly affected arteries include those located in the legs, arms, neck and kidneys. The vast majority of patients with PAD also have significant concomitant coronary artery disease (CAD) and a high proportion of morbidity and mortality in these patients is related to myocardial infarction, ischaemic stroke or cardiovascular death. It is estimated that approximately 27 million people in Western Europe and North America have PAD.^2-4

Cordis Corporation, part of Johnson & Johnson, develops and manufactures interventional vascular technology.

References:

1. The Chocolate PTA Balloon Catheter is not indicated for use in the coronary or cerebral vasculature.

2. 2011 ACCF/AHA Focused Update of the Guideline for the Management of patients with peripheral artery disease (Updating the 2005 Guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 2011 November 1;124(18):2020-45.

3. Belch JJ, Topol EJ, Agnelli G, Bertrand M, Califf RM, Clement DL et al. Critical issues in peripheral arterial disease detection and management: a call to action. Arch Intern Med 2003 April 28;163(8):884-92.

4. Lau JF, Weinberg MD, Olin JW. Peripheral artery disease. Part 1: clinical evaluation and noninvasive diagnosis. Nat Rev Cardiol 2011 July;8(7):405-18.