MARLBOROUGH, Mass.,
Sept. 28, 2015 /PRNewswire/
-- New 12-month clinical trial outcomes assessing the safety
and performance of the Boston Scientific (NYSE: BSX) Eluvia™
Drug-Eluting Vascular Stent System reflect a primary patency
rate1 of more than 96 percent. These results represent
the highest 12-month primary patency reported for an interventional
treatment of femoropopliteal artery lesions among comparable
trials. The Eluvia Stent System is an advanced treatment
option for patients with narrowing or blockages in the superficial
femoral artery (SFA) or proximal popliteal artery (PPA), a result
of peripheral artery disease (PAD).
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Results from the MAJESTIC trial, which were presented at the
Cardiovascular and Interventional Radiological Society of
Europe (CIRSE) annual meeting in
Lisbon, Portugal, also included a
low 12-month target lesion revascularization (TLR) rate of 3.8
percent, with no observed stent fractures and no
amputations.
"Achieving a 96 percent primary patency rate at one year, with
low major adverse events, is exceptional," 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. "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."
The MAJESTIC trial, a prospective, multicenter clinical trial,
enrolled 57 patients across Europe, Australia and New
Zealand, with an average lesion length of 70.8 mm. The trial
included a high percentage of complex lesions, with 46% of lesions
classified as total occlusions and 65% identified as severely
calcified.
Data from the MAJESTIC trial are expected to support global
regulatory submissions. In addition, Boston Scientific has received
an Investigational Device Exemption (IDE) from the Food and Drug
Administration (FDA) to begin a global, pivotal study of the Eluvia
Stent System. The study, named the IMPERIAL trial, is designed to
support future regulatory submissions and patient enrollment is
expected to begin in the coming months.
"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," said Jeff Mirviss, senior vice president and
president, Peripheral Interventions, Boston Scientific. "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."
About the Eluvia Stent System
The Eluvia Stent System
is the first stent specifically designed for deployment in the
superficial femoral artery (SFA) that utilizes the anti-restenotic
drug paclitaxel in conjunction with a polymer. This drug and
polymer combination is intended to facilitate sustained release of
the drug over the period of time when restenosis is most likely to
occur, preventing tissue growth that might otherwise block the
stented artery. The Eluvia Stent System is built on the Innova™
Stent System platform, consisting of a self-expanding nitinol stent
and an advanced, 6F low-profile triaxial delivery system for added
support and placement accuracy. The innovative stent architecture
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.
View or download an image of the Eluvia Stent System.
The Eluvia Stent System is pending CE Mark approval. In the
U.S., the Eluvia Stent System is an investigational device and is
not available for sale.
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 200 million
people are affected by PAD worldwide.
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).
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Statements
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the meaning of Section 27A of the Securities Act of 1933 and
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CONTACTS
Media: Trish Backes
Global Media Relations
Boston Scientific Corporation
651-582-5887 (office)
Trish.backes@bsci.com
Simonetta Balbi
39 3387936422 (mobile)
39 0106060281 (direct)
European Media Relations
Boston Scientific Corporation
Balbis@bsci.com
Investors: Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
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SOURCE Boston Scientific