ELUVIA drug eluting vascular stent, developed by Boston Scientific got hold of a CE mark to introduce it in Europe.
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.
‘Peripheral artery disease occurs when fatty (plaque) or calcified material builds up in the walls of the arteries and makes them narrower, thus restricting blood flow. When this occurs, the muscles in the legs cannot get enough blood and oxygen, especially during exertion such as exercise or walking.’
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.
"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," said Professor Stefan Müller-Hülsbeck, M.D., PhD, principal investigator at the Vascular Center Diako Flensburg and head of the Department of Diagnostic and Interventional Radiology / Neuroradiology, Academic Hospitals Flensburg, Germany.
"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."