Healthcare Industry News:  paclitaxel 

Devices Interventional

 News Release - November 3, 2011

Bayer HealthCare's MEDRAD Interventional Business Announces Five-Year Data of Cotavance(R) Drug Eluting Balloon with Paccocath(R) Technology to be Presented at 2011 TCT

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., Nov. 3, 2011 -- (Healthcare Sales & Marketing Network) -- 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.

About MEDRAD

The cardiovascular products of MEDRAD, Inc. were merged with the endovascular products of Possis Medical to form MEDRAD Interventional. Focused on the research and development of advanced technologies, MEDRAD Interventional designs, manufactures and markets devices that enable interventional physicians to better see and treat coronary and vascular disease.

MEDRAD, Inc. develops, markets and services medical devices used to diagnose and treat disease. Its product offerings include fluid injection systems for radiology and cardiology, endovascular devices for the treatment of cardiovascular disease, magnetic resonance-compatible accessories and equipment services. MEDRAD is a two-time recipient of the Malcolm Baldrige National Quality Award, the top honor a U.S. company can receive for quality and business excellence (2003 and 2010). The company's world headquarters is near Pittsburgh, Pa., in the United States. MEDRAD is a business of Bayer HealthCare. More company information is available at www.medrad.com.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.9 billion (2010), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec. 31, 2010) and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

(1) Paccocath, Cotavance and Ultravist are trademarks of Bayer Pharma AG


Source: MEDRAD

Issuer of this News Release is solely responsible for its content.
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