March 17, 2016 — Boston Scientific announced in late February that the Eluvia Drug-Eluting Vascular Stent System 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.
"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," said Prof. Stefan Müller-Hülsbeck, M.D., Ph.D., 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."
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. Enrollment began in Q4 2015 and the study will include approximately 485 patients in 75 sites worldwide.
For more information: www.bostonscientific.com