Medical device manufacturer Boston Scientific has received CE mark approval in the European Union for its Eluvia drug-eluting vascular stent system.
The Eluvia system has been developed to restore blood flow in the peripheral arteries above the knee, specifically the superficial femoral artery and proximal popliteal artery.
Featuring a drug-polymer combination, the system aims to facilitate sustained release of the drug (paclitaxel) that has the capacity to avoid narrowing (restenosis) of the vessel.
Based on Innova stent system platform, the Eluvia features a self-expanding nitinol stent and 6F low-profile triaxial delivery system for placement accuracy.
The CE Mark approval was based on data from the Majestic multicenter clinical trial, which demonstrated a primary patency rate of about 96%.
Boston Scientific peripheral interventions president and senior vice president Jeff Mirviss said: The availability of the Eluvia stent system to European patients, paired with the expansion of our existing clinical program, demonstrates the momentum of our drug-eluting portfolio in combatting peripheral artery disease."
The company has also secured an investigational device exemption (IDE) approval to carry out Imperial trial, which will evaluate the safety and efficacy of the Eluvia system compared to the Zilver PTX stent produced by Cook Medical.
The study, which started enrollment in last quarter, will recruit around 485 patients in 75 sites across the globe.
Image: Eluvia drug-eluting vascular stent system. Photo: courtesy of Boston Scientific Corporation.