MARLBOROUGH, Mass., Sept. 17,
2024 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) has received U.S. Food and Drug Administration (FDA)
approval to expand the indication for current-generation INGEVITY™+
Pacing Leads – thin wires placed inside the heart and connected to
an implantable device – to include conduction system pacing (CSP)
and sensing of the left bundle branch area (LBBA) when connected to
a single- or dual-chamber pacemaker.
Pacing of the LBBA is an alternative to traditional right
ventricular pacing for the treatment of symptomatic bradycardia, a
condition in which the heart beats too slowly. Through this pacing
approach, which uses the heart's natural electrical system, a lead
is placed in the LBBA of the heart's conduction system. This
technique may promote greater ventricular synchrony and reduce the
long-term risk of heart failure associated with traditional right
ventricular pacing.1
"This approval strengthens our broader initiative to provide
physicians with LBBA-specific tools and educational resources,
while reinforcing our commitment to developing safe and effective
pacing technologies," said Scott
Olson, senior vice president and president, Cardiac Rhythm
Management and Diagnostics, Boston Scientific. "We believe the
expanded indication for the INGEVITY+ Pacing Lead will enhance the
implant experience for physicians and connect this technology to
the growing number of patients who can benefit from LBBA
pacing."
Clinical evidence submitted to the FDA to support the expanded
indication included data from approximately 400 patients from the
INSIGHT-LBBA study – an analysis of INGEVITY+ pacing leads that
were previously implanted in the LBBA for anti-bradycardia pacing –
and supplemented with bench testing and LATITUDE™ Programming
System data.
"This expanded indication provides physicians using the
INGEVITY+ Pacing Lead the flexibility to determine the most
appropriate pacing strategy based on individual patient
characteristics," said Kenneth
Stein, M.D., senior vice president and global chief medical
officer, Boston Scientific. "Data has demonstrated this lead to be
safe and effective for LBBA pacing – a rapidly growing pacing
technique – allowing us to provide a new therapeutic option on a
proven lead that will further the quality of patient care."
The INGEVITY+ Pacing Lead is driven by a stylet during lead
placement, which supports positioning the device into a desired
location within the heart and allows for both continuous pacing and
impedance monitoring – key features that can aid appropriate
placement and fixation. The expanded indication follows the launch
of the Boston Scientific CSP portfolio – inclusive of the OneLINK™
Splitter Cable, INGEVITY+ Helix Locking Tool and site-selective
pacing delivery catheters – which is designed to support the safe
and effective placement of the INGEVITY+ Pacing Lead in the LBBA.
The INGEVITY+ lead received FDA approval in 2019 for use with
pacemakers and defibrillators.
More information on the INGEVITY+ Pacing Lead is available
here.
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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CONTACTS:
Steve Bailey
Media Relations
(651) 582-4343 (office)
Steve.Bailey@bsci.com
Jon Monson
Investor Relations
(508) 683-5450
BSXInvestorRelations@bsci.com
1 Sharma P et al. Clinical outcomes of left bundle
branch area pacing compared to right ventricular pacing: Results
from the Geisinger-Rush Conduction System Pacing Registry. Heart
Rhythm. 2021; 19:3-11
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SOURCE Boston Scientific Corporation