MARLBOROUGH, Mass.,
May 3, 2016 /PRNewswire/
-- Boston Scientific (NYSE: BSX) has received U.S. Food and
Drug Administration (FDA) approval for two catheters that can be
used with the Rhythmia™ Mapping System. The IntellaNav™ XP and the
IntellaNav MiFi™ XP navigation-enabled ablation catheters –
designed to map and ablate – were approved to treat Type I atrial
flutter, an abnormal rhythm of the upper chambers of the heart.
These are the first magnetically-tracked catheters that Boston
Scientific will offer to the U.S. market. Along with the immediate
launch of the catheters, the company is also releasing a software
enhancement for the Rhythmia Mapping System.
"By combining these new magnetic navigation-enabled catheters
with our high-density, high-resolution Rhythmia Mapping System, we
can create enhanced maps that help diagnose arrhythmias and improve
guidance during cardiac ablation procedures," said Kenneth Stein, M.D., chief medical officer,
Rhythm Management, Boston Scientific. "With these approvals, we
continue the expansion of our electrophysiology product offerings,
further demonstrating our commitment to help electrophysiologists
provide the highest quality of care for their patients."
Unlike conventional cardiac mapping systems, the Rhythmia
Mapping System rapidly and automatically generates
three-dimensional images of any chamber of the heart to help
diagnose, locate and treat the source of rhythm abnormality. The
Software Version 1.4 mapping system update improves the speed and
quality in which the images are acquired using a variety of
therapeutic and diagnostic catheters, including the IntellaNav XP
and IntellaNav MiFi XP catheters. The software update also provides
advanced editing capabilities, allowing for detailed visual
enhancements of the maps.
Both of the newly approved IntellaNav XP catheters feature
magnetic sensors which track the location of the catheter while
delivering radiofrequency energy into the heart muscle, creating
heat to destroy a small area of the tissue responsible for the
abnormal heart rhythm. The IntellaNav MiFi XP catheter also
provides increased accuracy and signal clarity via mini-electrode
technology which delivers a highly localized signal closely
reflecting what is happening at the tip in real-time during the
ablation procedure.
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 35 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
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CONTACTS:
Laura Aumann
Media Relations
Boston Scientific Corporation
(651) 582-4251 (office)
Laura.Aumann@bsci.com
Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
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SOURCE Boston Scientific