Medtronic "Conduction System Pacing" Expanded
Indication Now Includes Left Bundle Branch Area Pacing in Addition
to His-Bundle Pacing for Patients with Slow Heart Rates
DUBLIN, Oct. 17,
2022 /PRNewswire/ -- Medtronic plc (NYSE: MDT) today
announced it has received U.S. Food and Drug Administration (FDA)
approval for expanded labeling of a cardiac lead that taps into the
heart's natural electrical system, giving patients needed therapy
while avoiding complications sometimes associated with traditional
pacing methods, such as cardiomyopathy.1 Commonly
referred to as "conduction system pacing," this approach helps
ensure that pacing closely mimics the heart's physiologic
contractions, allowing the heart's ventricles to work in
coordination.1
Medtronic is the first and only company with therapies approved
for conduction system pacing. In 2018, the FDA approved the
SelectSecure™ MRI SureScan® Model 3830 cardiac lead for His-Bundle
pacing, another form of conduction system pacing. Now this cardiac
lead is approved for pacing and sensing at the bundle of His or in
the left bundle branch area as an alternative to apical pacing in
the right ventricle in a single- or dual-chamber pacing system.
These implanted pulse generator systems help patients who
experience slow heart rates (bradycardia).
This new approval adds to the Medtronic legacy of cardiac pacing
innovative "firsts," which include:
- The first leadless pacemaker (the Micra™ Transcatheter Pacing
System, launched in 2016 and expanded to patients with AV block in
2020)
- The first pacemaker approved for use in MRIs (the Revo® MRI
SureScan® pacing system launched in 2011), and
- The first wearable pacemaker invented by Medtronic founder
Earl Bakken in 1957.
"Conduction system pacing is more like simulating
natural activation and can yield positive outcomes for
patients," said Pugazhendhi Vijayaraman, M.D., F.H.R.S., director
of electrophysiology at Geisinger Heart Institute in Wilkes-Barre, Pa. "This approval signals to
physicians that the Model 3830 lead is safe and effective for
patients for conduction system pacing, and it may encourage more
physicians to learn the procedure."
The SelectSecure Model 3830 lead received approval for left
bundle branch area pacing based on real-world evidence showing high
procedural success rates at 92%, and low procedural complication
rates at 2.5%.2
Originally indicated in the U.S. for pacing and sensing in the
atrium or right ventricle, the MR-conditional, steroid-eluting,
bipolar SelectSecure Model 3830 lead has more than 20 years of
proven performance and reliability. The expanded indication for
left bundle branch area pacing was granted based on evidence from
multiple sources spanning more than 20,000 treated
patients.3 Now the SelectSecure Model 3830 lead is
the first and only lead approved for conduction system pacing.
"Physicians are telling us about their excitement for the future
of pacemakers, which will rely on conduction system and leadless
pacing," said Robert C. Kowal, M.D.,
Ph.D., general manager of Cardiac Pacing Therapies at Medtronic,
who joined Medtronic in 2017 after more than 17 years in
electrophysiology practice. "Expanded labeling of this lead allows
us to train physicians to successfully perform left bundle
procedures, bringing the benefits of conduction system pacing to
more patients."
1 Padala SK and Ellenbogen KA. Card
Electrophysiol Clin. 2021;13(4):755-84.
2 Ellenbogen KA, Fagan DH, Zimmerman P, et al. Left
bundle branch area pacing using the 3830 lumenless lead: A
systematic review and meta-analysis. Accepted at 15th Asia Pacific
Heart Rhythm Society Scientific Session. 20 November
2022.
3 Medtronic data on file.
About Medtronic
Bold thinking. Bolder actions. We are
Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global
healthcare technology company that boldly attacks the most
challenging health problems facing humanity by searching out and
finding solutions. Our Mission — to alleviate pain, restore health,
and extend life — unites a global team of 90,000+ passionate people
across 150 countries. Our technologies and therapies treat 70
health conditions and include cardiac devices, surgical robotics,
insulin pumps, surgical tools, patient monitoring systems, and
more. Powered by our diverse knowledge, insatiable curiosity, and
desire to help all those who need it, we deliver innovative
technologies that transform the lives of two people every second,
every hour, every day. Expect more from us as we empower
insight-driven care, experiences that put people first, and better
outcomes for our world. In everything we do, we are engineering the
extraordinary. For more information on Medtronic (NYSE:MDT), visit
www.Medtronic.com and follow @Medtronic on Twitter and
LinkedIn.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
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SOURCE Medtronic plc