Medtronic First To Obtain FDA Approval For Pacing The Coronary heart’s Pure Conduction System

Medtronic plc (NYSE: MDT) at present introduced it has obtained U.S. Meals and Drug Administration (FDA) approval for expanded labeling of a cardiac lead that faucets into the guts’s pure electrical system, giving sufferers wanted remedy whereas avoiding issues generally related to conventional pacing strategies, comparable to cardiomyopathy.1

Generally known as “conduction system pacing,” this strategy helps be sure that pacing carefully mimics the guts’s physiologic contractions, permitting the guts’s ventricles to work in coordination.1

Medtronic is the primary and solely firm with therapies permitted for conduction system pacing. In 2018, the FDA permitted the SelectSecure™ MRI SureScan® Mannequin 3830 cardiac lead for His-Bundle pacing, one other type of conduction system pacing. Now this cardiac lead is permitted for pacing and sensing on the bundle of His or within the left bundle department space as a substitute for apical pacing in the suitable ventricle in a single- or dual-chamber pacing system. These implanted pulse generator techniques assist sufferers who expertise sluggish coronary heart charges (bradycardia).

This new approval provides to the Medtronic legacy of cardiac pacing modern “firsts,” which embrace:

  • The primary leadless pacemaker (the Micra™ Transcatheter Pacing System, launched in 2016 and expanded to sufferers with AV block in 2020)
  • The primary pacemaker permitted to be used in MRIs (the Revo® MRI SureScan® pacing system launched in 2011), and
  • The primary wearable pacemaker invented by Medtronic founder Earl Bakken in 1957.

“Conduction system pacing is extra like simulating pure activation and might yield constructive outcomes for sufferers,” stated Pugazhendhi Vijayaraman, M.D., F.H.R.S., director of electrophysiology at Geisinger Coronary heart Institute in Wilkes-Barre, Pa. “This approval indicators to physicians that the Mannequin 3830 lead is protected and efficient for sufferers for conduction system pacing, and it could encourage extra physicians to be taught the process.”

The SelectSecure Mannequin 3830 lead obtained approval for left bundle department space pacing based mostly on real-world proof displaying excessive procedural success charges at 92%, and low procedural complication charges at 2.5%.2

Initially indicated within the U.S. for pacing and sensing within the atrium or proper ventricle, the MR-conditional, steroid-eluting, bipolar SelectSecure Mannequin 3830 lead has greater than 20 years of confirmed efficiency and reliability. The expanded indication for left bundle department space pacing was granted based mostly on proof from a number of sources spanning greater than 20,000 handled sufferers.3  Now the SelectSecure Mannequin 3830 lead is the primary and solely lead permitted for conduction system pacing.

“Physicians are telling us about their pleasure for the way forward for pacemakers, which can depend on conduction system and leadless pacing,” stated Robert C. Kowal, M.D., Ph.D., normal supervisor of Cardiac Pacing Therapies at Medtronic, who joined Medtronic in 2017 after greater than 17 years in electrophysiology follow. “Expanded labeling of this lead permits us to coach physicians to efficiently carry out left bundle procedures, bringing the advantages of conduction system pacing to extra sufferers.”

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 department space pacing utilizing the 3830 lumenless lead: A scientific evaluate and meta-analysis. Accepted at fifteenth Asia Pacific Coronary heart Rhythm Society Scientific Session. 20 November 2022.
3 Medtronic knowledge on file.