New FARAWAVE™ NAV Ablation Catheter and
FARAVIEW™ Software combine with OPAL HDx™ Mapping System to provide
visualization during pulsed field ablation
MARLBOROUGH, Mass., Oct. 18,
2024 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) today announced it has received U.S. Food and Drug
Administration (FDA) approval for the navigation-enabled FARAWAVE™
NAV Ablation Catheter for the treatment of paroxysmal atrial
fibrillation (AF) and FDA 510(k) clearance for the new FARAVIEW™
Software, which will combine to provide visualization for cardiac
ablation procedures with the FARAPULSE™ Pulsed Field Ablation (PFA)
System. These technologies are compatible exclusively with Boston
Scientific's existing cardiac mapping technology and the company's
latest offering, the OPAL HDx™ Mapping System.
Today, physicians may utilize a separate mapping catheter prior
to a cardiac PFA procedure to examine and analyze the heart's
electrical patterns and plan the therapeutic applications for each
patient. The FARAWAVE NAV Ablation Catheter builds upon the current
FARAWAVE catheter by adding magnetic navigation capabilities,
enabling cardiac mapping and PFA therapy delivery within a single
integrated catheter, while minimizing the need for additional
device exchanges. Mapped procedures with the FARAPULSE PFA System
are visually depicted for physicians via the FARAVIEW Software,
which offers a dynamic view of catheter placement, shape and
rotation.
"The addition of the FARAWAVE NAV Ablation Catheter and FARAVIEW
Software to our portfolio provides a next-level pulsed field
ablation mapping experience with cost-effective tools developed
specifically and uniquely for the FARAPULSE PFA System," said
Nick Spadea-Anello, president,
Electrophysiology, Boston Scientific. "Built on this safe and
clinically-proven platform – which has been used to treat more than
125,000 patients globally – the visualization capabilities offered
by these new technologies are designed to increase confidence in
therapy delivery and simplify mapped workflows during PFA
procedures."
The latest advancement within the Boston Scientific PFA
portfolio, the FARAVIEW Software magnetically tracks the FARAWAVE
NAV Ablation Catheter, which allows physicians to see where pulsed
fields have been applied and visualize cumulative therapy delivery
to guide ablation strategy. Delivery of PFA with the FARAWAVE NAV
Ablation Catheter can be tracked through automated tagging
technology, which is intended to assist physicians in planning,
executing and confirming application of therapy by showing the
approximate pulsed field locations within the heart, based on the
catheter's position.
"In clinical use, the FARAVIEW Software and FARAWAVE NAV
Ablation Catheter produced detailed cardiac maps that could improve
guidance, limit fluoroscopy times and assist physicians in
assessing the location of energy delivered during PFA procedures,"
said Vivek Reddy, M.D., director of
electrophysiology, Mount Sinai Fuster Heart Hospital, New York. "The addition of navigation and
visualization capabilities to the FARAPULSE PFA System could aid
workflow efficiency and enhance the treatment physicians can
provide to patients living with AF."
Boston Scientific will immediately launch the FARAWAVE NAV
Ablation Catheter and FARAVIEW Software in the U.S. More
information is available here.
*Dr. Vivek Reddy 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 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 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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