First-of-its-kind expandable cryoballoon
catheter advances cryoablation therapy, addresses key limitations
with traditional systems
MARLBOROUGH, Mass., Aug. 8, 2023
/PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today
announced it has received U.S. Food and Drug Administration (FDA)
approval for the POLARx™ Cryoablation System. The new system, which
is indicated for the treatment of patients with paroxysmal atrial
fibrillation (AF), features the POLARx FIT Cryoablation Balloon
Catheter, a device with the unique capability of enabling two
balloon sizes – 28 and 31mm – in one catheter.
Cryoablation is a minimally invasive procedure for treating AF
during which a balloon catheter delivers cryotherapy to the
pulmonary vein, freezing problematic tissue and creating scarring
that blocks irregular electrical signals. The system addresses
known limitations by reimagining existing cryoablation offerings,
allowing physicians to adjust and expand the new POLARx FIT
catheter to fit a patient's individual anatomy during an ablation
procedure, which can help mitigate time-consuming and disruptive
device changeouts. The device also allows physicians to treat a
wider range of pulmonary vein anatomies and create lesions in
optimal positions to better deliver therapy to areas of the heart
where disruptive signals that cause AF originate.
"The new POLARx Cryoablation System, and the expandable
cryoballoon catheter specifically, is an exciting development for
the effective treatment of AF as it allows physicians to better
tailor care for individual patients without sacrificing safety or
efficiency," said Wilber Su, MD,
FHRS, FACC, Director of Electrophysiology, Banner University. "As
we saw in clinical evaluation, the combination of maneuverability
and variable balloon sizes makes this system particularly useful in
addressing longstanding challenges with varying cardiac anatomies
and brings to the table occlusion capabilities physicians aren't
used to seeing with traditional systems."
Data from the FROZEN-AF IDE clinical trial – a global,
prospective, non-randomized, single-arm study presented at Heart
Rhythm 2023 – demonstrated the safety and effectiveness of the
POLARx Cryoablation System for the treatment of 385 patients with
paroxysmal AF. The primary event-free rate, or freedom from
procedure- or device-related events, was 96.0% at 12 months, with
no reports of moderate or severe pulmonary vein stenosis,
persistent phrenic nerve palsy or esophageal fistulas. At 12
months, the rate of freedom from documented atrial arrhythmias was
79.9%.
"The U.S. approval of the POLARx Cryoablation System, which has
been used in more than 25,000 patients worldwide to date, marks an
exciting advancement for the treatment of AF and a new era of
cryoablation capabilities," said Nick
Spadea-Anello, president, Electrophysiology, Boston
Scientific. "By prioritizing procedural flexibility and
individualized care, this offering transforms a key therapy in the
electrophysiology space, addresses the unmet needs of physicians
and affirms our commitment to making meaningful innovations to
established technologies."
The POLARx Cryoablation System received CE Mark in February of
2020 and Japanese Pharmaceuticals and Medical Devices Agency (PMDA)
approval in October of 2021. The POLARx FIT catheter received
approval in Europe, Japan, Canada
and other Asia Pacific markets in
2023.
More information on the POLARx Cryoablation System is available
here.
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 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. For more
information, visit www.bostonscientific.com and connect on 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. Wilber Su 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