MARLBOROUGH, Mass.,
Sept. 3, 2020 /PRNewswire/
-- Boston Scientific (NYSE: BSX) announced that the U.S.
Centers for Medicare and Medicaid Services (CMS) granted a New
Technology Add-on Payment (NTAP) for the Eluvia™ Drug-Eluting
Vascular Stent System as part of the 2021 Inpatient Prospective
Payment System (IPPS). The NTAP designation, awarded to new medical
devices determined to substantially improve the diagnosis or
treatment of Medicare beneficiaries, will be effective
on October 1, 2020 and will provide eligible hospitals with
incremental reimbursement for the Eluvia stent system for up to
three years. The Medicare criteria for an NTAP designation is
based on newness of the device, cost and a substantial clinical
improvement.
The Eluvia stent system was developed for the treatment of
peripheral artery disease (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.[i],[ii] 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 re-opens the blocked artery and restores blood flow,
while also utilizing a drug-polymer combination to offer a
sustained, low-dose release of drug to prevent tissue regrowth
within the stented artery.
"The CMS determination is a very positive development for
patients with PAD and supports what we have confirmed through our
clinical trials – the Eluvia stent offers clinically superior
outcomes compared to other peripheral drug-coated technology
available to clinicians and their patients," said Jeff Mirviss, executive vice president and
president, Peripheral Interventions, Boston Scientific. "The
decision is particularly important given the level of consideration
and evaluation related to the role of paclitaxel in the peripheral
vasculature, and we believe this designation reflects the unique
attributes of the Eluvia stent, which are clearly differentiated
and improve the quality of life for the millions of people
suffering from symptoms of PAD."
The NTAP designation will support access to the Eluvia stent for
Medicare beneficiaries in the hospital inpatient setting, making it
possible for eligible hospitals to receive NTAP payment in addition
to the standard Medicare Severity Diagnosis Related Group (MS-DRG)
payment.
The FDA approval of the Eluvia stent system in September 2018 was based on findings from the
IMPERIAL trial, which exhibited the highest 24-month primary
patency reported to date for the treatment of femoropopliteal
disease in a U.S. pivotal trial with a drug-coated balloon or
drug-eluting stent.[iii] Trial data confirmed a statistically
significant lower clinically-driven target lesion revascularization
(TLR) rate of 12.7% for patients treated with the Eluvia stent, in
contrast to 20.1% observed within the Zilver® PTX® Drug-Eluting
Peripheral Stent cohort (p=0.0495), thus reducing the need for
repeat procedures at 24 months.[iv]
Additional information on the Eluvia stent system can be found
online at www.bostonscientific.com/drugeluting.
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 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 www.bostonscientific.com and connect on Twitter and
Facebook.
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the meaning of Section 27A of the Securities Act of 1933 and
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Forward-looking statements may be identified by words like
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CONTACTS:
Karin Dalsin
Media Relations
(763) 494-1914 (office)
Karin.Dalsin@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
i Centers for Disease Control:
https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_pad.htm
Accessed July 19, 2019.
ii 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.
iii Highest-two year primary patency based on
24-month Kaplan-Meier estimates reported for IMPERIAL, IN.PACT SFA,
ILLUMENATE, LEVANT II and Primary Randomization for Zilver PTX
RCT.
iv Gray WA, Two-year Outcomes from the IMPERIAL
Randomized Head to Head Study of Eluvia DES and Zilver PTX. LINC,
January 2020.
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SOURCE Boston Scientific Corporation