MARLBOROUGH, Mass., April 8,
2024 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) has initiated the NAVIGATE-PF study of the
FARAVIEW™ Software Module* when it is used to visualize and track
the FARAWAVE™ Nav Pulsed Field Ablation (PFA) Catheter* for the
treatment of patients with paroxysmal and persistent atrial
fibrillation (AF). The FARAVIEW technology and the FARAWAVE Nav
catheter expand the capabilities of the FARAPULSE™ PFA System
through integration with our cardiac mapping system.
In a pulsed field cardiac ablation procedure, a catheter is
guided into the heart to administer targeted non-thermal electrical
fields that selectively treat heart tissue cells, while avoiding
damage to nearby structures. Before PFA therapy application, a
physician might employ a separate cardiac mapping catheter to
examine and analyze the heart's electrical patterns to plan the PFA
applications. The FARAWAVE Nav PFA Catheter adds magnetic
navigation capabilities to the current FARAWAVE PFA catheter,
enabling detailed mapping and PFA therapy within the same device.
This mapping data is visualized using the new FARAVIEW Software
Module, offering a tailored mapping solution for procedures with
the FARAPULSE PFA System.
"Creating a detailed cardiac map during an ablation procedure
can improve guidance, reduce fluoroscopy times and assist
physicians in assessing the location of energy delivered, which may
improve patient outcomes," said Ignacio García-Bolao, M.D.,
Ph.D., study investigator and director of cardiology and
cardiovascular surgery, Clinica Universidad de Navarra, Pamplona,
Spain. "Through this study, we
hope to identify the procedural benefits of the FARAWAVE Nav
catheter, which can both map and ablate, alongside technology that
allows for magnetically-tracked, dynamic visualization of a
patient's cardiac anatomy and catheter configuration."
In the prospective, single-arm, open-label,
multi-center NAVIGATE-PF study, approximately 30 patients at
several European centers who live with paroxysmal or persistent AF
will be enrolled. All patients in the study will have cardiac
mapping performed during their procedures. Those living with
paroxysmal AF will undergo pulmonary vein isolation, while patients
with persistent AF will undergo additional posterior wall isolation
at the discretion of the physician performing the procedure.
"This study seeks to build on the compelling performance of
the FARAPULSE PFA System by providing an integrated mapping
and navigation experience for physicians," said Brad Sutton, M.D., chief medical officer, AF
Solutions, Boston Scientific. "Adding navigation and visualization
capabilities to this PFA system, which is leading the way in terms
of safety, efficacy and efficiency, is an exciting proposition for
physicians and patients alike."
Boston Scientific anticipates U.S. regulatory approval of
the FARAWAVE NAV PFA Catheter and the FARAVIEW Software Module in
the second half of 2024.
More information on the FARAPULSE PFA System is available
here.
*Caution: Investigational Device. Limited by Federal (or US) law
to investigational use only. Not available for sale.
** Dr. Ignacio Garcia-Bolao is a paid consultant of Boston
Scientific Corporation. He has not been compensated in connection
with this press release.
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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SOURCE Boston Scientific Corporation