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02-23-2016, 09:28 PM
Boston Sci’s ELUVIA Drug Eluting Stent Cleared in Europe
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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.
From Boston Sci:
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.
Via:*Boston Scientific… (http://news.bostonscientific.com/2016-02-22-Boston-Scientific-Receives-CE-Mark-For-Eluvia-Drug-Eluting-Vascular-Stent-and-An**unces-Initiation-of-New-Clinical-Trial)
The post Boston Sci’s ELUVIA Drug Eluting Stent Cleared in Europe (http://www.medgadget.com/2016/02/boston-scis-eluvia-drug-eluting-stent-cleared-europe.html) appeared first on Medgadget (http://www.medgadget.com).
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http://www.medgadget.com/wp-content/uploads/2016/02/ELUVIA.jpg
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.
From Boston Sci:
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.
Via:*Boston Scientific… (http://news.bostonscientific.com/2016-02-22-Boston-Scientific-Receives-CE-Mark-For-Eluvia-Drug-Eluting-Vascular-Stent-and-An**unces-Initiation-of-New-Clinical-Trial)
The post Boston Sci’s ELUVIA Drug Eluting Stent Cleared in Europe (http://www.medgadget.com/2016/02/boston-scis-eluvia-drug-eluting-stent-cleared-europe.html) appeared first on Medgadget (http://www.medgadget.com).
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