Long-Term Data Affirm Durability Of Medtronic’s EV-ICD

Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. This edition is an update on Medtronic's Extravascular ICD (EV-ICD).

Cardiovascular Catch-Up
• Source: Shutterstock

Long-term findings from the pivotal study of Medtronic’s Extravascular Implantable Cardioverter Defibrillator (EV ICD), including patients followed through an average of 17 months, showed that the system frequently terminates tachycardia with pacing instead of a defibrillator shock.

Medtronic's EV ICD

Like other "leadless" cardiac rhythm management devices, Medtronic's EV ICD avoids some of the risks of traditional, transvenous ICDs with a lead installed under the sternum instead of in a vein in the heart. 

The generator is implanted in the left mid-axillary region below the left armpit. The system also offers anti-tachycardia pacing (ATP), pause-prevention pacing, and a device similar in size, shape, and battery longevity to transvenous ICDs.

The EV ICD system is not yet approved for sale or distribution in the US, it is available in Europe under the brand name Aurora EV ICD. (Also see "Minute Insight: Medtronic’s Extravascular ICD Earns European Approval" - Medtech Insight, 21 February, 2023.)

It competes directly with Boston Scientific's Emblem MRI subcutaneous ICD. (Also see "Medtronic’s Extravascular ICD Hits Targets In Trial; Will Soon Compete With Boston Scientific’s S-ICD" - Medtech Insight, 31 August, 2022.)

EV ICD complements Medtronic's Micra line of leadless pacemakers. (Also see "Minute Insight: Medtronic Counters Abbott With New Micra Leadless Pacemakers" - Medtech Insight, 1 May, 2023.)

Principal Investigator Paul Friedman of the Mayo Clinic in Minnesota presented the long-term results at Heart Rhythm 2023 on 20...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By 

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
• By 

Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.

More from R&D

Abbott Launches Next-Gen Delivery System For Proclaim DRG Neurostim

 
• By 

Allen Burton, Abbott’s medical director of neuromodulation told Medtech Insight that the delivery system was developed to make the procedure easier for physicians, especially those who perform the implantations infrequently.

Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.