Pioneering technology has demonstrated potential to improve
safety for patients with paroxysmal atrial fibrillation and
simplify procedures for physicians
MENLO PARK, Calif.,
March 3, 2021 /PRNewswire/ -
FARAPULSE Inc. today announced the first patients were treated in
the ADVENT Trial, a U.S. Food and Drug Administration (FDA)
Investigational Device Exemption (IDE) pivotal trial to evaluate
the safety and effectiveness of its Pulsed Field Ablation (PFA)
system for the treatment of paroxysmal Atrial Fibrillation (AF). AF
is a heart rhythm disorder that affects nearly 6 million Americans
and makes them five times more likely to have a stroke than
individuals with a regular heartbeat. The first patients were
treated at New York's Mount Sinai
Hospital by Dr. Vivek Reddy, the
Helmsley Trust Professor of Medicine at the Icahn School of
Medicine at Mount Sinai and the trial's Principal
Investigator.
"The ADVENT Trial is uniquely positioned to change our
field: it is not only the first pivotal trial of PFA but also the
only randomized one approved to commence by the FDA. I fully
expect that when complete, this trial will provide definitive
evidence for a change in how electrophysiologists treat patients
with AF," said Dr. Reddy. "Mount Sinai Heart fosters innovation in
medicine, evidenced by our first enrollments in this landmark
clinical study."
"On the basis of our preclinical and clinical data beginning in
2013, FARAPULSE PFA represents a generational breakthrough in the
treatment of AF," said Allan
Zingeler, President and CEO of FARAPULSE. "We believe PFA
will simplify the ablation procedure for physicians and increase
its safety margin by practically eliminating many of the procedural
risks associated with today's standard of care. We are eager to
prove this in the ADVENT Trial, which will be conducted by
more than 50 leading electrophysiologists across the U.S."
Ablation is a non-surgical procedure used to correct certain
heart rhythm abnormalities such as AF. During an ablation
procedure, a thin, flexible tube called a catheter is guided to the
interior of the heart from the patient's groin. Traditionally, the
tip of an ablation catheter generates extreme temperatures – hot or
cold – to eliminate the targeted heart tissue associated with
irregular heartbeats. The PFA system, however, relies on
non-thermal electric fields that are tissue-selective. That is, PFA
selectively ablates heart tissue without affecting other critical
surrounding structures such as the esophagus or major nerves – an
unfortunate potential downside of standard thermal ablation
procedures. Based on European clinical trials, these electric
fields have proven very effective in durably "silencing" abnormal
heart signals, while reducing the risk of damage to other nearby
tissues.
More than 170 patients have been treated with the FARAPULSE PFA
system in European feasibility studies. Dr. Reddy and colleagues
have published extensively on the FARAPULSE system, with key
findings highlighted most recently in the July 2019 and September
2020 issues of The Journal of the American College of
Cardiology.
About The ADVENT Trial
The ADVENT Trial is a
randomized controlled trial that will involve at least 350 patients
in over 30 U.S. centers. Patients will be randomized in a 1:1
fashion to either FARAPULSE PFA or standard ablation, using
radiofrequency or cryoballoon ablation. The primary endpoint will
be freedom from AF for twelve months after a single ablation
procedure. Dr. Vivek Reddy, Director
of Cardiac Electrophysiology for The Mount Sinai Health
System, is the trial's Principal Investigator.
About FARAPULSE and PFA
Today, all forms of cardiac
ablation to treat arrhythmias are thermal. While both
radiofrequency and cryo-ablation have evolved, they nonetheless
carry an inherent risk of indiscriminate thermal damage.
Tissue-selective FARAPULSE PFA has emerged to be one of the most
promising energy sources for cardiac ablation, including pulmonary
vein isolation to treat Atrial Fibrillation. Leading with safety,
FARAPULSE PFA makes durable cardiac lesions in seconds while
sparing non-target tissue. FARAPULSE is pioneering tissue-selective
PFA therapy through development and commercialization of its
dedicated generator (FARASTAR), PVI-focused catheter (FARAWAVE),
large-area focal catheter (FARAFLEX), precision focal catheter
(FARAPOINT) and a proprietary deflectable delivery sheath
(FARADRIVE). The FARAPULSE PFA system, which includes FARAWAVE,
FARASTAR and FARADRIVE, received CE mark approval in January 2021 and is commercially available across
Europe.
Disclosure
Dr. Vivek
Reddy receives financial compensation as a consultant and
holds stock options in the study sponsor, Farapulse. Dr. Reddy also
received financial compensation from other companies that
manufacture devices used in the treatment of atrial
fibrillation.
CAUTION-Investigational device. Limited by Federal (or
United States) law to
investigational use. Not Available for Sale.
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SOURCE FARAPULSE Inc.