Data represent first five-year evaluation of target lesion revascularization rates with Cotavance balloon catheter compared to standard balloon angioplasty in PAD patients

WARRENDALE, PA -- MEDRAD Interventional, a business of Bayer HealthCare, today announced that five-year data from the THUNDER trial will be presented at the 2011 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, in San Francisco. The data will focus on five-year rates of target lesion revascularization comparing the Cotavance® drug eluting balloon (DEB) catheter with Paccocath® Technology to standard balloon angioplasty (POBA) in popliteal arteries of patients with peripheral arterial disease (PAD). Presented by Prof. Dr. med. Thomas Zeller of Herz-Zentrum, Bad Krozingen, Germany, during the TCT-sponsored symposium, "Drug-Coated Balloons: Clinical Data and Applications," at 2 p.m. PST Nov. 10, the results will continue to build on the long-term clinical experience with the Paccocath® technology, which is available in Europe, but not yet approved in the U.S.

"The only published positive long-term clinical results to date with drug-eluting balloons have used MEDRAD's Paccocath technology, and these new data will now provide additional information out to five years, the longest time studied among DEBs," said Jack Darby, Senior Vice President of MEDRAD Interventional. "We remain committed to further elucidating long-term clinical outcomes with the Cotavance paclitaxel eluting balloon catheter compared to or in combination with other interventional therapies through our large clinical studies and registry program. Collectively, this will include more than 1,700 patients and approximately 200 centers around the world."

MEDRAD Interventional will have an extensive presence at the 2011 TCT conference. In addition to the presentation of new five-year data, MEDRAD is supporting two symposia, Management of Thrombus in STEMI Interventions: Discussion and Debate on the Role of AngioJet Thrombectomy and Manual Aspiration (Wednesday, Nov. 9, breakfast symposium), and Long-term Clinical Data of Paccocath Technology, Preclinical Evidence, and Planned Cotavance DEB Peripheral Study Designs (Thursday, Nov. 10, luncheon symposium). The MEDRAD Interventional exhibit booth will include information on its broad range of devices and display products from Pathway Medical Technologies, a recent acquisition that places MEDRAD Interventional as an emerging leader in revascularization solutions.

About Cotavance with Paccocath Technology

The Cotavance balloon catheter is to be used in percutaneous interventions for the treatment of peripheral arterial disease for balloon dilation of stenotic lesions in the iliac and infrainguinal arteries while applying paclitaxel to the vessel wall to inhibit restenosis. The Paccocath technology is a proprietary drug matrix applied to the balloon of an angioplasty catheter. The matrix consists of paclitaxel, long used in drug-eluting stents to treat cardiovascular disease, and a radiologic contrast agent, Ultravist® 370.(1) When the balloon is inflated to dilate the narrowed vessel, paclitaxel is delivered directly to the diseased area. The Cotavance catheter received CE Mark certification in Europe in 2011. MEDRAD Interventional is moving forward with the Investigational Device Exemption (IDE) process as one of the steps in gaining FDA approval for Cotavance product in the United States.

SOURCE: MEDRAD Interventional