Non-for-profit org Viva Physicians said yesterday that it will lead a pan-industry effort to study the use of paclitaxel-eluting devices for the treatment of peripheral artery disease in above-the-knee applications.
The initiative comes on the heels of a meta-analysis published in the Journal of the American Heart Association this month showing a potential link between increased long-term mortality outcomes and paclitaxel devices.
Companies with commercial drug-coated balloons and drug-eluting stents, including Medtronic (NYSE:MDT), Boston Scientific (NYSE:BSX) and Philips (NYSE:PHG), have agreed to give Viva de-identified, patient-level data from clinical programs.
“Due to recent discussion around the safety of paclitaxel-eluting devices, both Viva and our industry partners firmly believe in the need for an analysis of this nature to better address some of these concerns,” Dr. Krishna Rocha-Singh, a co-founding member of Viva’s board, said in prepared remarks. “We are all committed to working together in a transparent, timely, and defined manner and look forward to making this research publicly available to the clinical community.”