LAS VEGAS and MARLBOROUGH, Mass., Oct. 6, 2021 /PRNewswire/ -- Today, Boston
Scientific Corporation (NYSE: BSX) announced positive data for the
Eluvia™ Drug-Eluting Vascular Stent System (Eluvia stent) during a
late-breaking clinical trial presentation at the Vascular
InterVentional Advances (VIVA) meeting in Las Vegas. Data presented included one-year
results from the EMINENT trial, which demonstrated superiority of
the Eluvia stent compared to self-expanding bare metal stents (BMS)
for the treatment of patients with peripheral artery disease (PAD)
and superficial femoral artery (SFA) or popliteal artery (PPA)
lesions up to 210 mm in length. The study enrolled 775 patients,
making it the largest randomized trial of a drug-eluting stent for
the treatment of PAD to date.
In the trial, the Eluvia stent exhibited superiority with a
primary patency rate of 85.4% versus 76.3% with BMS
(p=0.0077).1 The analysis also confirmed a
significantly greater rate of sustained clinical improvement
without reintervention, 83.0% for patients treated with the Eluvia
stent compared to 76.6% for those treated with BMS (p=0.0450).
Further, there was no significant difference in major adverse
events or all-cause mortality rates between patients treated with
the Eluvia stent and those treated with BMS through one year.
"I am honored to have been part of this global study, which adds
to the robust body of evidence from the IMPERIAL trial and confirms
that the Eluvia stent should be considered the stent of choice for
treating SFA and PPA lesions of intermediate length," said
Professor Yann Gouëffic, M.D.,
Department of Vascular and Endovascular Surgery at Paris
Saint-Joseph Hospital, France and
principal investigator of the EMINENT study.2 "The
superior primary patency rates and greater rates of clinical
improvement without reintervention are reassuring for physicians
looking to make clinically-based treatment decisions for their
patients and reduce the need for repeat procedures."
The Eluvia stent was developed for the treatment of PAD – the
narrowing of the arteries of the legs due to plaque buildup – which
affects approximately 8.5 million people in the United States and more than 200 million
people worldwide.3,4 Left untreated, PAD restricts
blood flow to the legs and feet and patients often experience pain,
swelling and a diminished quality of life. The Eluvia stent, which
features sustained release of the lowest dose of paclitaxel of any
peripheral drug-eluting device, re-opens blocked arteries and
restores blood flow while utilizing a drug-polymer combination to
prevent tissue regrowth.
"We are committed to meaningful clinical trials designed to
evolve clinical practice, and on the heels of the positive RANGER
II SFA data presented yesterday, we are pleased that the EMINENT
trial establishes the Eluvia stent as the first drug-eluting stent
to demonstrate superior primary patency rates compared to bare
metal stents in a head-to-head randomized trial," said Michael R. Jaff, D.O., chief medical officer and
vice president clinical affairs, technology and innovation,
Peripheral Interventions, Boston Scientific. "The breadth of our
portfolio, as the only company offering both a drug-coated balloon
and a drug-eluting stent for the treatment of patients with PAD,
provides physicians with evidence-based and highly-differentiated
treatment options."
For more information on the Eluvia stent, visit
www.bostonscientific.com/eluviaclinicaltrials.
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 40 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 and connect on Twitter and Facebook.
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the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements may be identified by words like
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Item 1A – Risk Factors in our most recent Annual Report on Form
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CONTACTS:
Karin Dalsin
Media Relations
(763) 494-1914
Karin.Dalsin@bsci.com
Lauren Tengler
Investor Relations
(508) 683-4479
BSXInvestorRelations@bsci.com
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1 Kaplan
Meier estimate
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2
Professor Yann Gouëffic is a paid consultant for Boston Scientific
Corporation. He has not been compensated for his quote within this
press release.
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3 Centers
for Disease Control:
https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_pad.htm Accessed
September 2, 2021.
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4 Shu, J.
& Santulli, G. (2018, August). Update on peripheral artery
disease: Epidemiology and evidence-based facts. Atherosclerosis
Journal, 275(1), 379-381. doi:
https://doi.org/10.1016/j.atherosclerosis.2018.05.033.
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SOURCE Boston Scientific Corporation