WARRENDALE, Pa., Nov. 10, 2011 /PRNewswire/ -- Bayer HealthCare’s affiliate MEDRAD, Inc. today announced that five-year data from the THUNDER trial* demonstrated a 59 percent relative reduction in target lesion revascularization (TLR) rates in popliteal arteries of patients with peripheral arterial disease (PAD) treated with the Cotavance® drug eluting balloon with Paccocath® technology compared to standard balloon angioplasty (POBA). Additionally, for patients requiring TLR, the average time to revascularization before TLR was extended by 448 days in patients treated with the Cotavance catheter, which is available in Europe, but not yet approved in the U.S. MEDRAD is currently 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.
The data were presented at the 2011 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, in San Francisco as part of a TCT-sponsored symposium titled, “Drug-Coated Balloons: Clinical Data and Applications.”
“These data with Bayer HealthCare’s Paccocath technology represent the only five-year clinical TLR outcomes in comparison to standard balloons,” said Prof. Dr. med. Gunnar Tepe of Klinikum Rosenheim in Rosenheim, Germany, principal investigator of THUNDER. “The results demonstrate clear long-term benefits for patients with the Cotavance paclitaxel eluting balloon for reducing the number of TLR procedures and extending the time before a revascularization might be needed in PAD patients.” Dr. med. Thomas Zeller of Herz-Zentrum, Bad Krozingen, Germany, who presented the data at the TCT symposium, added, “Beginning as early as the first year and continuing through year five, a consistent 30 to 40 percent improvement was seen with the Cotavance catheter in avoiding TLR. TCT was an excellent venue to share these ground-breaking data.”
Details of the data from THUNDER at five years were as follows:
- TLR rates were 22.9 percent for the Cotavance catheter (11 of 48 patients) compared to 55.6 percent for POBA (30 of 54 patients)
- The mean time to TLR was 792.5 days in Cotavance catheter treated patients compared to 344.0 days with POBA, p=0.007
- Estimates for freedom from TLR at five years (based on Kaplan-Meier curves) were 76 percent for the Cotavance group compared to 42.7 percent for the POBA group, and overall the long-term TLR probability was lower with the Cotavance catheter compared to POBA (log-rank p< 0.01)
- Long-term results were similar comparing dissected arteries vs. non-dissected arteries
- No differences were seen between groups for patient deaths or those lost to follow-up
About Cotavance
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, Pennsylvania, 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 health care, 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.
* Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 2008;358:689-699.
(1) Paccocath, Cotavance, and Ultravist are trademarks of Bayer Pharma AG
SOURCE Bayer HealthCare-MEDRAD, Inc.
