MARLBOROUGH, Mass.,
June 1, 2020 /PRNewswire/
-- Boston Scientific (NYSE: BSX) announced the U.S. launch of
the DIRECTSENSE™ Technology, a tool for monitoring the effect of
radiofrequency (RF) energy delivery during cardiac ablation
procedures. Available on the RHYTHMIA HDx™ Mapping System, the
DIRECTSENSE Technology, which received U.S. Food and Drug
Administration approval in April, is the only tool to monitor
changes in local impedance – electrical resistance – around the tip
of the INTELLANAV™ MiFi Open-Irrigated (OI) ablation catheter,
offering physicians an additional measurement of therapy effect
during an ablation.
Ablation is a treatment option for patients with cardiac
arrhythmias in which physicians use a catheter to create lesions
and destroy heart tissue that causes abnormal rhythms. The
DIRECTSENSE Technology provides data on the impedance around the
catheter tip to measure the ability of the tissue to respond to RF
energy before physicians deliver therapy. During ablation, the tool
tracks the change in local impedance which, in conjunction with
other measures, offers physicians a distinct understanding of
tissue characteristics and how they are affecting that tissue.
These insights may indicate temperature change in the tissue,
helping to reduce the chances of over-ablation and avoid
complications.
"Knowing the change in impedance around the tip of the catheter
provides unique information about local tissue characteristics and
the development of the lesion," said David
J. Callans, M.D., professor of medicine at the Perelman
School of Medicine, University of
Pennsylvania – the first center to use the new technology in
the U.S. "Unlike existing products on the market, the DIRECTSENSE
Technology assists physicians in evaluating pre-ablation tissue
health, while supporting better clinical understanding of how they
are influencing that tissue to guide minimal, predictable ablation
during a procedure."
According to chronic data from the LOCALIZE clinical trial, a
retrospective analysis of the DIRECTSENSE Technology presented by
Ignacio Garcia-Bolao, M.D., director of cardiology and
cardiovascular surgery, University of
Navarra, Pamplona, Spain at
Heart Rhythm Society 2020 Science, a local impedance decrease of
≥16.6 ohms with an inter-lesion spacing of ≤ 6mm showed a ≥ 98%
positive predicative value of durable pulmonary vein block at three
months in patients with paroxysmal atrial fibrillation (AF).
"Building upon the success seen with the DIRECTSENSE Technology
in Europe, we are pleased to
introduce this tool to physicians and their patients in the U.S.,"
said Kenneth Stein, M.D., senior
vice president and chief medical officer, Rhythm Management and
Global Health Policy, Boston Scientific. "This approval marks an
exciting milestone for our growing electrophysiology portfolio,
providing physicians a more direct understanding of lesions and
procedural efficiency to obtain optimal patient outcomes."
The company continues to expand its electrophysiology offerings
with the recently granted CE Mark for the POLARx™ Cryoablation
System and plans to launch the product and begin enrolling European
patients in a post-approval registry with the device in the coming
months. The addition of this new single-shot therapy, alongside
existing products and services, affirms the company's commitment to
providing meaningful advancements for the treatment of patients
with AF.
For more information on the Boston Scientific portfolio of
electrophysiology products please visit:
www.bostonscientific.com/rhythmia.
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 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 and
Facebook.
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US Media:
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Media Relations
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Steve.Bailey@bsci.com
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SOURCE Boston Scientific Corporation