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Bayer HealthCare's Cotavance® Drug Eluting Balloon With Paccocath® Technology Reduced Five-Year Target Lesion Revascularization Rates by 59 Percent in PAD Patients Compared to Those Treated With Uncoated Balloon
Date:11/10/2011

etails 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 d
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SOURCE Bayer HealthCare-MEDRAD, Inc.
Copyright©2010 PR Newswire.
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