• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FDA approves expanded label for heart pacing from Medtronic

FDA approves expanded label for heart pacing from Medtronic

October 18, 2022 By Sean Whooley

Medtronic HIS bundle Heart Illustration
The HIS Bundle. [Image from Medtronic]
Medtronic (NYSE:MDT) announced that it received expanded FDA approval for a cardiac lead that taps into the heart’s natural electrical system.

This process is commonly referred to as “conduction system pacing,” according to Medtronic. It gives patients needed therapy while avoiding complications sometimes associated with traditional pacing methods, like cardiomyopathy.

Fridley, Minnesota-based Medtronic said this helps to ensure that pacing closely mimics the heart’s physiologic contractions. It allows the heart’s ventricles to work in coordination. The SelectSure MRI SureScan Model 3830 first received FDA approval in 2018 for HIS-Bundle pacing.

The cardiac lead’s expanded approval covers pacing and sensing at the HIS-Bundle or in the left bundle branch area. It represents an alternative to apical pacing in the right ventricle in a single- or dual-chamber pacing system. The implanted pulse generator system helps those with slow heart rates (bradycardia), Medtronic said.

A first for Medtronic

Medtronic says the approval makes it the first company to receive a nod for pacing the heart’s natural conduction system.

“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, Pennsylvania. “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.”

Real-world evidence showed high procedural success rates at 92%. It also demonstrated low complication rates at 2.5% in the left bundle branch area.

“Physicians are telling us about their excitement for the future of pacemakers, which will rely on conduction system and leadless pacing,” said Dr. Robert C. Kowal, GM, cardiac pacing therapies at Medtronic. “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.”

Filed Under: Cardiac Implants, Cardiovascular, Featured, Implants, News Well, Structural Heart Tagged With: Medtronic

More recent news

  • Aurora Spine begins first procedures with Aero lumbar fusion system
  • Caranx Medical surgical robot TaviPilot AI software wins FDA clearance
  • InspireMD launches carotid stent in U.S. after FDA approval
  • Neuros Medical raises $56M Series D to support nerve stim tech
  • CorWave reports first-in-human LVAD implant

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy