MARLBOROUGH, Mass., Sept. 27,
2024 /PRNewswire/ -- Boston Scientific
Corporation (NYSE: BSX) announced it has received Pharmaceuticals
and Medical Device Agency (PMDA) approval in Japan for the FARAPULSE™ Pulsed Field Ablation
(PFA) System. The FARAPULSE PFA System, which is indicated for the
isolation of pulmonary veins in the treatment of paroxysmal atrial
fibrillation (AF), is a novel alternative to standard-of-care
thermal ablation treatment.
"The FARAPULSE PFA System is the most clinically studied PFA
system and its use in treating more than 125,000 patients globally
to date continues to reinforce its strong safety, efficacy and
efficiency profile," said Nick
Spadea-Anello, president, Electrophysiology, Boston
Scientific. "The rapid adoption of the FARAPULSE PFA System, which
is now approved in more than 65 countries, indicates a paradigm
shift for the treatment of paroxysmal AF – one that has clinical
benefits to both physicians and patients – and we look forward to
bringing this differentiated technology to Japan."
AF can lead to increased risk of death, stroke and heart
failure1 and affects more than one million people in
Japan,2 while worldwide
AF prevalence is conservatively estimated to impact 38 million
individuals.3 Unlike traditional thermal ablation, which
uses extreme heat or cold to ablate cardiac tissue associated with
AF, the FARAPULSE PFA System uses non-thermal electrical fields
that avoid damage to surrounding structures.
"Clinical evidence and extensive real-world use have
demonstrated the FARAPULSE PFA System to be an efficient and more
predictable procedure than traditional thermal ablation and a
proven safe technology," said Kazuhiro
Satomi, M.D., Ph.D., professor, Department of Cardiology and
director, Heart Rhythm Center, Tokyo Medical University Hospital.
"This technology has the potential to rapidly advance clinical
practice and improve outcomes and is anticipated to further expand
the range of treatment options for AF that can be tailored to each
patient's condition."
Adding to its robust body of clinical evidence for the FARAPULSE
PFA System, Boston Scientific expects to initiate the OPTION-A
clinical trial in Japan,
China, Taiwan and Hong
Kong in early 2025 to study the safety and efficacy of
concomitant procedures using the FARAPULSE PFA System for cardiac
ablation and the WATCHMAN FLX™ Pro Left Atrial Appendage
Closure Device.
Boston Scientific plans to launch the FARAPULSE PFA System in
Japan in the coming weeks,
following reimbursement approval. More information on the FARAPULSE
PFA System 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 45 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 health care. 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,"
"intend" and similar words. These forward-looking statements
are based on our beliefs, assumptions and estimates using
information available to us at the time and are not intended to be
guarantees of future events or performance. These
forward-looking statements include, among other things, statements
regarding our business plans, clinical trials, and product
launches, performance and impact. If our underlying
assumptions turn out to be incorrect, or if certain risks or
uncertainties materialize, actual results could vary 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 factors) could
affect our ability to implement our business strategy and may cause
actual results to differ materially from those contemplated by the
statements expressed in this press release. As a result,
readers are cautioned not to place undue reliance on any of our
forward-looking statements.
Factors that may cause such differences include, among other
things: future economic, competitive, reimbursement and regulatory
conditions; manufacturing, distribution and supply chain
disruptions and cost increases; variations in outcomes of ongoing
and future clinical trials and market studies; new product
introductions; demographic trends; intellectual property;
litigation; financial market conditions; and future business
decisions made by us and our competitors. All of these factors are
difficult or impossible to predict accurately and many of them are
beyond our control. For a further list and description of
these and 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 Exchange Commission, which we may update in Part II,
Item 1A – 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
statements to reflect any change in our expectations or in events,
conditions or circumstances on which those expectations may be
based, or that may affect the likelihood that actual results will
differ from those contained in the forward-looking statements,
except as required by law. This cautionary statement is
applicable to all forward-looking statements contained in this
document.
CONTACTS:
Becca Johnson
Media Relations
Rebecca.johnson@bsci.com
Jon Monson
Investor Relations
+1 (508) 683-5450
BSXInvestorRelations@bsci.com
1 Bordignon S, Chiara Corti M, Bilato C. Atrial
Fibrillation Associated with Heart Failure, Stroke and Mortality. J
Atr Fibrillation. 2012 Jun 15;5(1):467. doi: 10.4022/jafib.467.
PMID: 28496747; PMCID: PMC5153082.
2 Ohsawa M, Okayama A, Sakata K, Kato K, Itai K,
Onoda T, Ueshima H. Rapid increase in estimated number of persons
with atrial fibrillation in Japan:
an analysis from national surveys on cardiovascular diseases in
1980, 1990 and 2000. J Epidemiol. 2005 Sep;15(5):194-6. doi:
10.2188/jea.15.194. PMID: 16195640; PMCID: PMC7904304.
3 Lippi G, Sanchis-Gomar F., et al. Global
epidemiology of atrial fibrillation: An increasing epidemic and
public health challenge. Int J Stroke. 2021; Feb
16:217-221.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/boston-scientific-receives-japanese-regulatory-approval-for-the-farapulse-pulsed-field-ablation-system-302260792.html
SOURCE Boston Scientific Corporation