Boston Scientific touts 3-year data for Eluvia paclitaxel-eluting vascular stent
The trial, which enrolled 57 patients with symptomatic lower limb ischemia and lesions in the superficial femoral artery or proximal popliteal artery, had a primary patency rate of 83.5% through two years.
After three years, 85.3% of patients were experiencing freedom from target lesion revascularization, the company reported.
“Over the course of the Majestic trial, the majority of the patients, including those with relatively challenging lesions, have remained largely symptom-free,” principal investigator Dr. Stefan Müller-Hülsbeck said in prepared remarks. “The sustained drug release enabled by the polymer-based stent can be credited with reduced reinterventions over a three-year period, as well as establishing a long-term safety profile in the femoropopliteal arteries.”
Boston Scientific also recently finished enrolling 485 patients in the head-to-head Imperial trial, which is slated to compare the Eluvia stent system to Cook Medical’s Zilver PTX stent. Initial results, which Boston Scientific anticipates it will have by next year, will be used to support regulatory submissions for Eluvia in the U.S. and Japan.
“It is reassuring to see the demonstrated long-term durability of the Eluvia Stent System and we look forward to continuing to expand the clinical knowledge within the peripheral application of drug-eluting technologies,” Jeff Mirviss, president of Peripheral Interventions at Boston Scientific, added. “We are fully committed to advancing therapies that can benefit patients suffering from lower limb ischemia, a group that is often times lacking successful treatment options that help avoid the possibility of experiencing amputations.”
The Eluvia stent won CE Mark clearance in February last year.