Boston Scientific got hold of a CE mark to introduce the ELUVIA drug eluting vascular stent in Europe. Designed for delivery into the leg arteries above the knee, the superficial femoral and proximal popliteal, the polymer stent keeps the lumen open by releasing paclitaxel that prevents restenosis.
From Boston Sci:
CE Mark approval was based on data from the MAJESTIC trial, a prospective, multicenter clinical trial that assessed the safety and performance of the Eluvia Stent System and reflected a primary patency rate of more than 96 percent1. The MAJESTIC trial results represented the highest 12-month primary patency reported for an interventional treatment of femoropopliteal artery lesions among comparable trials.
Boston Scientific received an Investigational Device Exemption (IDE) to conduct a global, prospective trial called the IMPERIAL trial, which will assess the safety and efficacy of the Eluvia Stent System compared to the Zilver® PTX® Stent manufactured by Cook Medical. Enrollment began in Q4 last year and the study will include approximately 485 patients in 75 sites worldwide.
Via: Boston Scientific…