MARLBOROUGH, Mass., April 28, 2015 /PRNewswire/ -- In an important clinical advancement in the treatment of peripheral artery disease (PAD), a key trial evaluating the Boston Scientific (NYSE: BSX) Eluvia™ Drug-Eluting Vascular Stent System met its primary endpoint, with more than 94 percent of the lesions treated remaining open at nine months post implantation. This was accompanied by a target lesion revascularization rate (TLR) of less than four percent.
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Results from the MAJESTIC trial were presented today at the 37th Charing Cross International Symposium in London. The trial enrolled 57 patients across Europe, Australia and New Zealand with an average lesion length of 70.8 mm.
"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," said Professor Stefan Muller-Hulsbeck, M.D., PhD, principal investigator and chairman, Vascular Center Diako Flensburg and Head of the Department of Diagnostic and Interventional Radiology / Neuroradiology, Academic Hospitals Flensburg, Germany. "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."
Nine-month data from the MAJESTIC trial demonstrated the following
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a primary patency rate1 of 94.4 percent;
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a target lesion revascularization (TLR) rate of 3.6 percent; and
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no deaths or amputations.
The Eluvia Stent System is the first stent purpose-built for the superficial femoral artery (SFA) that utilizes a polymer and paclitaxel combination designed to facilitate a sustained drug release to reduce restenosis. The Eluvia Stent System is built on the Innova™ Stent System platform consisting of a self-expanding nitinol stent with a paclitaxel-eluting biostable polymer matrix loaded on an advanced, low-profile delivery system. The innovative stent architecture, designed specifically for the SFA, features a closed-cell design at each end of the stent for more predictable deployment, and an open-cell design along the stent body for improved flexibility, strength and fracture resistance. A triaxial delivery system is designed for added support and placement accuracy.
"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," said Jeff Mirviss, president, Peripheral Interventions, Boston Scientific. "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."
The Eluvia Stent System is pending CE Mark and is not available for use or sale in the U.S. The Ranger™ Paclitaxel-Coated PTA Balloon Catheter has CE Mark approval and is not available for use or sale in the U.S.
About Peripheral Artery Disease
Peripheral artery disease is a circulatory disorder that results from a build-up of plaque in one or more of the arteries, most often in the legs. As the disease progresses, plaque accumulation may significantly reduce blood flow through the arteries, resulting in pain and increasing disability, with severe cases often leading to amputation of the affected limb. It is estimated that 12-14 percent of the general population is affected by PAD2.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
- Primary patency defined as duplex ultrasound peak systolic velocity ratio ≤2.5 and absence of TLR or bypass; Data reflect actual values (not Kaplan Meier estimates)
- Shammas NW (2007). "Epidemiology, classification, and modifiable risk factors of peripheral arterial disease". Vasc Health Risk Manag 3 (2): 229–34. doi:10.2147/vhrm.2007.3.2.229. PMC 1994028. PMID 17580733
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