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:
- a primary patency rate1 of 94.4 percent;
- a target lesion revascularization (TLR) rate of 3.6 percent;
and
- 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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Boston Scientific Corporation
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SOURCE Boston Scientific Corporation