CE Mark for Eluvia drug-eluting vascular stent system -Boston Scientific

Boston Scientific announced that the Eluvia Drug-Eluting Vascular Stent System has received CE Mark and is commencing commercialization immediately in the European Union and other countries where CE Mark is recognized.

The Eluvia Stent System is designed to restore blood flow in the peripheral arteries above the knee – specifically the superficial femoral artery and proximal popliteal artery. The stent features a unique drug-polymer combination intended to facilitate sustained release of the drug (paclitaxel) that can prevent narrowing (restenosis) of the vessel, often the cause of pain and disability for patients diagnosed with peripheral artery disease. 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 percent . The MAJESTIC trial results represented the highest 12-month primary patency reported for an interventional treatment of femoropopliteal artery lesions among comparable trials.

Comment: Eluvia will compete with Cook Medical's Zilver PTX drug-eluting stent for PAD. This stent secured FDA approval in 2012.

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. Enrollment began in Q4 last year, 2015, and the study will include approximately 485 patients in 75 sites worldwide.