First coronary drug-coated balloon in U.S.
provides safe, effective alternative to treat coronary in-stent
restenosis and reduce risk of reoccurrence
MARLBOROUGH, Mass., March 1,
2024 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) today announced it has received U.S. Food and Drug
Administration (FDA) approval for the AGENT™ Drug-Coated Balloon
(DCB), which is indicated to treat coronary in-stent restenosis
(ISR) in patients with coronary artery disease. ISR is the
obstruction or narrowing of a stented vessel by plaque or scar
tissue.
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"With more than 100,000 patients treated globally to date in
both clinical and commercial settings, we are very pleased to
introduce this proven therapy as the first drug-coated coronary
balloon in the U.S," said Lance
Bates, president, Interventional Cardiology Therapies,
Boston Scientific. "The AGENT DCB addresses a critical unmet need
by providing a dedicated treatment option for the challenging
condition of ISR and we look forward to offering U.S. physicians
the opportunity to treat their patients with this novel
device."
While the stenting of coronary lesions continues to show a
substantial improvement in quality of life for patients with
coronary artery disease, ISR still encompasses 10 percent of
percutaneous coronary interventions in the U.S.1,2
Serving as an alternative to traditional therapies such as balloon
angioplasty, additional layers of stenting or radiation, the AGENT
DCB is a paclitaxel-coated balloon catheter that transfers a
therapeutic dose of drug to the vessel wall to help prevent ISR
reoccurrence.
Following Breakthrough Device Designation granted for the
technology by the FDA in 2021, the approval was supported by
positive results from the multicenter, prospective, randomized
controlled AGENT IDE trial, which enrolled 600 patients at 40 U.S.
sites.3 In the prespecified interim analysis of the
first 480 patients enrolled, the study met the primary endpoint of
target lesion failure (TLF) at 12 months with the AGENT DCB
demonstrating statistical superiority to uncoated balloon
angioplasty (17.9% vs. 28.7%; P=0.006).4,5 Findings also
included zero definite/probable cases of clotting within the stent
(0.0% vs. 3.9%, P=0.001), a 49% risk reduction in heart attack at
the target vessel (6.4% vs. 12.3%, P=0.03) and low adverse event
rates at 12 months.
"The AGENT IDE trial demonstrated that the AGENT DCB is an
effective and safe treatment option for coronary in-stent
restenosis, even in a high-risk population, which included many
individuals with multi-layer stents or diabetes," said principal
investigator Dr. Robert W. Yeh,
section chief of interventional cardiology at the Beth Israel
Deaconess Medical Center. "Treating ISR has been challenging in the
U.S. with limited therapies available, and this new technology will
help physicians reduce the risk of restenosis without radiation or
introducing additional metal layers, which do not provide an
adequate result for some patients."
The AGENT DCB is available in Europe, parts of Asia Pacific and Latin America for the treatment of patients
with ISR and previously untreated small vessel coronary disease.
Boston Scientific plans to launch the technology in the U.S. in the
coming months.
More information on the AGENT DCB is available here.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
technologies 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. Our portfolio of devices and
therapies helps physicians diagnose and treat complex
cardiovascular, respiratory, digestive, oncological, neurological
and urological diseases and conditions. Learn more at
www.bostonscientific.com and connect on LinkedIn and
X, formerly Twitter.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within
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
"anticipate," "expect," "project," "believe," "plan," "estimate,"
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forward-looking statements include, among other things, statements
regarding our business plans and product performance and impact,
and new and anticipated product approvals and launches. If
our underlying assumptions turn out to be incorrect, or if certain
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materially from the expectations and projections expressed or
implied by our forward-looking statements. These factors, in
some cases, have affected and in the future (together with other
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other important risks and uncertainties that may affect our future
operations, see Part I, Item 1A – Risk Factors in our most
recent Annual Report on Form 10-K filed with the Securities and
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Risk Factors in Quarterly Reports on Form 10-Q we have filed
or will file hereafter. We disclaim any intention or
obligation to publicly update or revise any forward-looking
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CONTACTS:
Angela Mineo
Media Relations
+1 (763) 955-8325 (office)
Angela.mineo@bsci.com
Jon Monson
Investor Relations
+1 (508) 683-5450
BSXInvestorRelations@bsci.com
* Dr. Robert Yeh is a paid
consultant of Boston Scientific Corporation. He has not been
compensated in connection with this press release.
1 Shlofmitz E, Iantorno M, Waksman R. Restenosis of
Drug-Eluting Stents: A New Classification System Based on Disease
Mechanism to Guide Treatment and State-of-the-Art Review. Circ
Cardiovasc Interv. 2019 Aug;12(8):e007023. doi:
10.1161/CIRCINTERVENTIONS.118.007023.
2 Moussa ID, Mohananey D, Saucedo J, et al. Trends and
outcomes of restenosis after coronary stent implantation in
the United States. J Am Coll
Cardiol. 2020;76:1521-1531.
3 Yeh RW, Bachinsky W, Stoler R, et al. Rationale and
design of a randomized study comparing the AGENT drug coated
balloon to plain old balloon angioplasty in patients with In-stent
restenosis. American Heart Journal. 2021;241:101-107.
doi:10.1016/j.ahj.2021.07.008.
4 AGENT IDE Clinical Trial data presented at TCT
2023 by Dr. Robert Yeh.
5 TLF was defined as myocardial infarction relative to
the target vessel, the need for a target lesion revascularization
(TLR) procedure or cardiac mortality.
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SOURCE Boston Scientific Corporation