Vascular News has learned from industry sources at the CIRSE annual meeting (Lisbon, Portugal, 15–19 September) that Bayer HealthCare is looking into discontinuing the production of the Cotavance drug-eluting balloon, using the Paccocath technology, as there have been problems of drug adhesion to the balloon. Industry sources told Vascular News that there have been cases of drug coming off the surface of the balloon before implantation. On being questioned on the topic, Bayer said that it has suspended its development programme for Cotavance only in the United States, due to recent regulatory changes – regulatory pathway in the USA is now seven years.
“Bayer Medical Care has suspended its US development programme for Cotavance in light of recent regulatory and market changes. This corresponds to our continuous prioritisation process. Cotavance is presently marketed in selected European countries where we continue to serve Cotavance customers. Current clinical studies outside the USA, including EuroCANAL, COPACABANA and Definitive AR, continue at currently active sites,” Bayer said in a statement to Vascular News.
Vascular News has also learned that companies have had difficulties with getting drug-eluting balloons reimbursed in Germany. Intellectual property issues have also been reported.
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. When the balloon is inflated to dilate the narrowed vessel, paclitaxel is delivered directly to the diseased area.
At CIRSE, Gunnar Tepe, Rosenheim, Germany, presented on the five-year angiographic follow-up of patients treated with uncoated balloons vs. Cotavance paclitaxel drug-coated balloon. Data from the THUNDER trial demonstrated a 59% relative reduction in target lesion revascularisation rates in popliteal arteries of patients with peripheral arterial disease treated with the Cotavance drug-eluting balloon compared to standard balloon angioplasty. Additionally, for patients requiring target lesion revascularisation, the average time to revascularisation before target lesion revascularisation was extended by 448 days in patients treated with the Cotavance catheter.