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."
|SOURCE Bayer HealthCare-MEDRAD, Inc.|
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