Boston Scientific receives CE Mark approval for Eluvia vascular stent

Boston Scientific has announced that its Eluvia drug-eluting vascular stent system has been approved in Europe.

The device is the first polymer-based drug-eluting stent designed to treat peripheral lesions above the knee to receive European CE Mark approval, having demonstrated its effectiveness in the MAJESTIC clinical trial.

It features a unique drug-polymer combination that can facilitate the sustained release of the drug paclitaxel to prevent narrowing of the vessel, a phenomenon that often causes pain and disability for peripheral artery disease patients.

In the MAJESTIC trial, Eluvia demonstrated a primary patency rate of more than 96 percent. This was the highest 12-month primary patency reported for an interventional treatment of femoropopliteal artery lesions among comparable trials.

Jeff Mirviss, senior vice-president and president for peripheral interventions at Boston Scientific, said: "The availability of the Eluvia Stent System to European patients, paired with the expansion of our existing clinical programme, demonstrates the momentum of our drug-eluting portfolio in combatting peripheral artery disease."

Another study called IMPERIAL is currently being conducted to support the company's efforts to secure approval for the stent in the US and Asia.