Nine-Month Data From MAJESTIC Study of Boston Scientific's Eluvia Peripheral DES Presented at Charing Cross

April 28, 2015—Favorable early results from a study of Boston Scientific Corporation’s Eluvia Drug-Eluting Vascular Stent System were presented during the 37th annual Charing Cross International Symposium in London. Professor Stefan Müller-Hülsbeck, MD, PhD, shared the 9-month data from MAJESTIC, a single-arm, multicenter study that enrolled 57 patients and 57 lesions, with a mean length of 70.8 mm. Prof. Müller-Hülsbeck is principal investigator of MAJESTIC, and Chairman of the Vascular Center Diako Flensburg and Head of the Department of Diagnostic and Interventional Radiology/Neuroradiology, Academic Hospitals Flensburg, Germany. 

Speaking with Endovascular Today at Charing Cross, Prof. Müller-Hülsbeck highlighted that these first-in-human data show that the combination of a nitinol skeleton with paclitaxel and a polymer has shown no disadvantages in terms of safety or efficacy.

Key among the data were a primary patency rate of 94.4%, a target lesion revascularization rate of 3.6%, and no deaths or amputations. Primary patency was defined as peak systolic velocity ratio ≤ 2.5 and absence of target lesion revascularization or bypass; the data reported reflect the actual value rather than Kaplan Meier estimates. Improvements in ankle-brachial index and Rutherford category were also noted. 

Prof. Müller-Hülsbeck described the Eluvia device, which is based on Boston Scientific’s Innova nitinol stent platform, as having a paclitaxel-eluting biostable polymer matrix designed to allow for sustained release of the antirestenotic drug. The stent itself has a closed cell design at its proximal and distal ends, and an open cell design through the main body. This combination aims to provide predictable deployment as well as the flexibility needed in the superficial femoral artery. The Eluvia stent is placed via a triaxial delivery system that can be controlled with one hand, which Prof. Müller-Hülsbeck commented makes delivery easy and accurate. 

Twelve-month data are expected to be announced in Q3 this year. Look for an extended interview with Prof. Müller-Hülsbeck on MAJESTIC and other topics in the May edition of Endovascular Today.