Boston Scientific receives CE mark for drug-eluting stent
Boston Scientific’s first polymer-based, drug-eluting stent designed to treat peripheral lesions above the knee approved in Europe
Boston Scientific Eluvia Drug-Eluting Vascular Stent System has received CE Mark and is commencing commercialisation immediately in the European Union and other countries where CE Mark is recognised.
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 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, according to Boston Scientific.
CE Mark approval was based on data from the MAJESTIC trial, a prospective, multicenter clinical trial that the company said assessed the safety and performance of the Eluvia Stent System and reflected a primary patency rate of more than 96%.
The MAJESTIC trial results represented the highest 12-month primary patency reported for an interventional treatment of femoropopliteal artery lesions among comparable trials, according to Boston Scientific.
Stefan Müller-Hülsbeck, principal investigator at the Vascular Center Diako Flensburg and head of the Department of Diagnostic and Interventional Radiology / Neuroradiology, Academic Hospitals Flensburg, Germany, said: “The exceptional 12-month results presented in the MAJESTIC trial, which included a high percentage of patients with complex lesions, demonstrate that this technology is a safe and efficacious solution for patients needing stents for the treatment of peripheral artery disease.
“The approval is a testament to the strength of the data and will be welcome news to physicians and patients who have not previously had access to a polymer based, drug-eluting stent, specifically developed for the superficial femoral and proximal popliteal arteries.”
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.
Jeff Mirviss, senior vice president and president, peripheral interventions, Boston Scientific, 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.
“Our legacy with drug-eluting technology combined with our commitment to further advance treatment options for peripheral artery disease, enables Boston Scientific to continue bringing ground breaking solutions for patients around the world.”