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Drug-Eluting Vascular Stent Receives CE Mark, New Trial Underway
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Boston Scientific recently announced that its drug-eluting vascular stent system has received CE mark, according to a press release.
CE mark approval was based on results of the prospective, multicenter MAJESTIC trial, which assessed the safety and performance of the Eluvia Drug-Eluting Vascular Stent System in patients with femoropopliteal artery lesions. In that study, the 12-month primary patency rate was more than 96%, according to the release.
“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 Stefan Müller-Hülsbeck, MD, PhD, principal investigator at the Vascular Center Diako Flensburg and head of the department of diagnostic and interventional radiology/Neuroradiology at Academic Hospitals Flensburg, Germany, stated in the release.
The Eluvia stent system features a drug-polymer combination to facilitate sustained release of paclitaxel and is designed to restore blood flow in the superficial femoral and proximal popliteal arteries, according to the release.
In addition, Boston Scientific was recently granted an Investigational Device Exemption to conduct the global, prospective IMPERIAL trial. The study will enroll 485 patients at 75 international sites and is designed to assess the safety and efficacy of the Eluvia stent system compared with the Zilver PTX stent (Cook Medical). Enrollment began in the fourth quarter of 2015, according to the release.
Disclosure: Müller-Hülsbeck reports consulting for Boston Scientific and Terumo, receiving travel grants from Boston Scientific and receiving speaker fees from Boston Scientific, Cordis, GE and Terumo.