Strong clinical evidence base, largest volume
of real-world use reinforce safety, efficacy and
efficiency advantages of the system
MARLBOROUGH, Mass., Jan. 31,
2024 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) announced it has received U.S. Food and Drug
Administration (FDA) approval for the FARAPULSE™ Pulsed Field
Ablation (PFA) System. The FARAPULSE PFA System is indicated for
the isolation of pulmonary veins in the treatment of
drug-refractory, recurrent, symptomatic, paroxysmal (i.e.,
intermittent) atrial fibrillation (AF) and is a unique new
alternative to standard-of-care thermal ablation treatment.
"The approval of the FARAPULSE PFA System marks an important
milestone for the millions of people living with paroxysmal AF and
is an incredible opportunity to bring the first PFA system designed
and built solely for this type of ablation therapy to physicians in
the U.S.," said Nick Spadea-Anello,
president, Electrophysiology, Boston Scientific. "A high bar has
been set by performance of the system in clinical and commercial
settings – where more than 40,000 patients have been treated to
date – and we look forward to continuing to lead the way with this
differentiated technology in the growing PFA space."
During a traditional ablation procedure, a catheter is guided to
the interior of the heart and generates extreme temperatures – hot
or cold – to destroy targeted areas associated with abnormal heart
rhythms. The FARAPULSE PFA System, however, relies on
tissue-selective, non-thermal electric fields to ablate heart
tissue and avoid damage to surrounding structures. Positive
12-month data from the pivotal ADVENT clinical trial – the first
randomized clinical trial to directly compare the efficacy and
safety of the system against standard-of-care ablation – found that
therapy with the device was as safe and effective as conventional
thermal ablation, with statistically shorter ablation times and a
quick learning curve for physicians. Additional real-world data
from more than 17,000 patients in the MANIFEST-17K registry
demonstrated continued real-world safety of the system, with no
reports of permanent phrenic nerve palsy, pulmonary vein stenosis
or esophageal injury.
"Within the ADVENT clinical trial, the FARAPULSE PFA System was
shown to be a safe, effective and efficient option for treating
paroxysmal AF, and extensive global real-world use has mirrored
that profile," said Vivek Reddy,
M.D., director of electrophysiology, Mount Sinai Fuster Heart
Hospital, New York. "Tissue
preferentiality and long-term efficacy, combined with markedly
shorter procedure times and learning curves, position the FARAPULSE
PFA System with strong potential to become a practice-changing
technology for both U.S. physicians and patients alike."
The FARAPULSE PFA System delivers pulsed field energy and
consists of the FARAWAVE™ Ablation Catheter, the FARASTAR™ Ablation
Generator, and the FARADRIVE™ Steerable Sheath, which is
complemented by the VersaCross Connect™ Access Solution for the
FARADRIVE Steerable Sheath to provide safe and efficient access to
the left side of the heart during procedures with the system. The
FARAWAVE catheter is used to treat a range of pulmonary vein
anatomies using an over-the-wire catheter with variable basket and
flower shapes, allowing the device to adapt to individual patient
anatomies. These configurations reinforce ease-of-use for
physicians and promote reproducible procedures between
operators.
Boston Scientific completed enrollment in the first phase of the
ADVANTAGE AF clinical trial in the third quarter of 2023, which is
studying the system for the treatment of patients with
drug-refractory, symptomatic, persistent AF, and commenced
enrollment in a second phase of the study to evaluate the safety
and effectiveness of adjunctive use of the FARAPOINT™ PFA Catheter
for cavotricuspid isthmus (CTI) ablations, a procedure used to
treat atrial flutter. The company also recently commenced the AVANT
GUARD clinical trial to evaluate the safety and efficacy of the
system as a first-line treatment for persistent AF compared to
anti-arrhythmic drug therapy.
The FARAPULSE PFA System was granted Breakthrough Device
Designation from the Center for Devices and Radiological Health
(CDRH) of the U.S. FDA in 2019 and received CE Mark in 2021. Boston
Scientific plans to immediately launch the system in the U.S. The
company is developing a navigation-enabled version of the FARAWAVE
catheter alongside the FARAVIEW™ Software Module and anticipates
regulatory approval in 2024.
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 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.
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CONTACTS:
Steve
Bailey
Media Relations
(651)
582-4343 (office)
Steve.Bailey@bsci.com
Lauren Tengler
Investor Relations
(508) 683-4479
BSXInvestorRelations@bsci.com
*Dr. Vivek Reddy is a paid
consultant of Boston Scientific Corporation. He has not been
compensated in connection with this press release.
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SOURCE Boston Scientific Corporation