Boston Scientific (NYSE:BSX) today said a small clinical trial of its Eluvia drug-eluting stent for treating peripheral artery disease met its primary endpoint at 9 months.
The 57-patient Majestic study enrolled subjects with superficial femoral artery lesions averaging 70.8mm in length, Boston Scientific said. Results were presented today at the Charing Cross International Symposium in London.
Nine months after implantation with the Eluvia stent, Majestic produced a primary patency rate of 94.4%, a target lesion revascularization (TLR) rate of 3.6% and no deaths or amputations. The study’s primary efficacy endpoint was 94%, Boston Scientific said.
"I have not seen clinical data this impressive for a vascular stent that has to perform in an environment as challenging as the superficial femoral artery. Because of forces created by knee flexion, there is an increased risk of restenosis, but we are seeing little evidence of this in the Majestic trial," principal investigator Dr. Stefan Müller-Hülsbeck of Germany’s Vascular Center Diako Flensburg said in prepared remarks.
Boston Scientific said CE Mark approval for the Eluvia stent is pending in the European Union. The device is not available at al in the U.S., the company said.
"The Eluvia stent system strengthens our leadership in peripheral technologies and further demonstrates our commitment to developing innovative and effective therapies for the treatment of peripheral artery disease," president Jeff Mirviss said in a prepared statement. "Together with our Ranger drug-coated balloon, we are providing important new tools for physicians to address a serious condition and make a meaningful difference in the lives of their patients."