MARLBOROUGH, Mass.,
Sept. 24, 2018 /PRNewswire/
-- Today, Boston Scientific (NYSE: BSX) announced that the
U.S. Food and Drug Administration (FDA) has approved its
Premarket Approval (PMA) application to market the
Eluvia™ Drug-Eluting Vascular Stent System, specifically
developed for the treatment of peripheral artery disease (PAD). The
Eluvia stent utilizes a drug-polymer combination to offer sustained
release of the drug paclitaxel for a one-year timeframe, designed
to prevent tissue regrowth that might otherwise block the stented
artery.
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Approximately 8.5 million people in the United States are affected by PAD, which
occurs when fatty or calcified atherosclerotic material, called
plaque, builds up on the walls of the arteries of the legs,
restricting blood flow and causing pain, swelling and a diminished
quality of life.1 If blood flow is not restored and
maintained, severe cases of PAD can lead to pain, ulcers and even
amputation of the affected limb.
"Over the past decade, we've seen significant advancements in
the treatment of peripheral artery disease, yet clinical and
economic outcomes still present an opportunity for innovation and
to improve patient care," said Jeff
Mirviss, senior vice president and president, Peripheral
Interventions, Boston Scientific. "With the FDA's approval of the
Eluvia stent, we can now bring the transformative power of
sustained drug release to clinicians and the millions of patients
suffering from this terrible disease."
The FDA's approval is based on findings from the IMPERIAL trial,
in which the Eluvia stent demonstrated superior results in the
first superficial femoral artery head-to-head drug-eluting stent
trial. 2 In this trial, patients treated with the Eluvia
stent experienced a significantly greater 12-month primary
patency of 88.5 percent, compared to 79.5 percent in patients
treated with Zilver PTX (p=0.0119).3 In addition,
patients treated with the Eluvia stent experienced half the target
lesion revascularization rate of Zilver PTX at 12 months, a 4.5
percent TLR rate for Eluvia versus 9.0 percent TLR rate for the
Zilver PTX cohort.
"In the IMPERIAL trial, the Eluvia stent demonstrated landmark
vessel patency and freedom from target lesion revascularization
rates, preventing more than 95 percent of patients from needing a
reintervention after one year," said William Gray, M.D., system chief, Division of
Cardiovascular Diseases and president, Lankenau Heart Institute at
Main Line Health in Wynnewood,
Pennsylvania, and co-principal investigator of the IMPERIAL
trial. "The Eluvia stent is a breakthrough therapy that marks a
significant step forward in the treatment of peripheral artery
disease, and now with its approval and commercial availability, it
has the potential to make an immediate impact on the quality and
value of care that physicians can provide to their patients."
The Eluvia stent system is built on the Innova™ Stent
System platform, a self-expanding nitinol stent that has been
designed for use in the superficial femoral and proximal popliteal
arteries, the main arteries that supply blood to the legs. The
Eluvia stent system received CE Mark in 2016.
- Centers for Disease Control:
https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_pad.htm
Accessed September 14, 2018
- Superiority determined in Post Hoc Superiority Analysis.
12-Month Primary Patency rate of 86.8 percent in the Eluvia arm vs.
77.5 percent in the Zilver PTX arm (p-value = 0.0144).
- Kaplan Meier Estimate
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.
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Statements
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statements within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934.
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CONTACTS:
Timette Nevala
Media Relations
Boston Scientific Corporation
(763) 494-1284 (office)
Timette.Nevala@bsci.com
Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
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SOURCE Boston Scientific Corporation