Boston Scientific (NYSE:BSX) said today that a 12-month study of its Eluvia drug-eluting stent reported a primary patency of 96%, which the company claims is the highest reported for a femoropopliteal artery lesion treatment for patients with peripheral artery disease.
The palitaxel-coated Eluvia stent is the 1st stent designed to be deployed in the superficial femoral artery, Boston Scientific said. Results from the Majestic trial were presented at the Cardiovascular and Interventional Radiological Society of Europe’s annual meeting in Lisbon, Portugal.
“Achieving a 96% primary patency rate at 1 year, with low major adverse events, is exceptional. In my opinion, the sustained release of paclitaxel enabled by this technology could represent a significant advancement in the treatment of patients with peripheral arterial disease,” principal investigator Dr. Stefan Müller-Hülsbeck of Flensburg, Germany’s Vascular Center Diako Flensburg said in prepared remarks.
The 57-patient 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 Marlborough, Mass.-based company said.
“The Majestic trial demonstrates our commitment to bringing forward innovative therapies that can make a difference in the lives of patients with PAD who face risks of serious complications including infections and amputations. The Eluvia Stent is built on a foundation of more than 15 years of design, development and clinical leadership in drug-eluting technologies at Boston Scientific,” peripheral interventions prez Jeff Mirviss said in a press release.
Boston Scientific hopes data from the trial will support global regulatory submissions, and said it received Investigational Device Exemptoin from the FDA to begin a pivotal study of the stent. Patient enrollment is slated to begin in the coming months, the company said.