Boston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for its Eluvia peripheral vessel stent for above-the-knee procedures.
Marlborough, Mass.-based Boston Scientific said it plans to immediately begin commercializing the Eluvia drug-eluting stent in Europe and other nations that recognize the mark. The paclitaxel-coated Eluvia stent is indicated for treating lesions in the superficial femoral and proximal popliteal arteries, the company said.
“The availability of the Eluvia stent system to European patients, paired with the expansion of our existing clinical program, demonstrates the momentum of our drug-eluting portfolio in combatting peripheral artery disease,” peripheral interventions president Jeff Mirviss said in prepared remarks. “Our legacy with drug-eluting technology, combined with our commitment to further advance treatment options for peripheral artery disease, enables Boston Scientific to continue bringing ground breaking solutions for patients around the world.”
“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,” added principal investigator Dr. Stefan Müller-Hülsbeck, of Germany’s Vascular Center Diako Flensburg and the Academic Hospitals Flensburg. “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.”
The 57-patient Majestic trial enrolled patients with an average lesion length of 70.8 mm, with 46% having lesions classified as total occlusions and 65% classified as severely calcified. The study showed a primary patency rate of 96% after a year.
Boston Scientific said today that an investigational device exemption trial, called Imperial, is designed to compare Eluvia device with Cook Medical’s Zilver PTX stent. Enrollment in the 485-patient trial began during the 4th quarter last year, the company said.
