Boston Scientific got hold of a CE mark to introduce the ELUVIA Drug Eluting vascular Stent in Europe. Designed for delivery into the leg arteries above the knee, the*superficial femoral and proximal popliteal, the polymer Stent keeps the lumen open by releasing*paclitaxel that prevents reste**sis.
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.
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 last year and the study will include approximately 485 patients in 75 sites worldwide.
02-23-2016, 09:28 PM
Boston Sci’s ELUVIA Drug Eluting Stent Cleared in Europe
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