Medtronic heartware devices: 2 updates

Medtronic, a medtech company based in Ireland, reported two recent updates to its heart devices:

1. Medtronic wins 1st FDA approval for conduction system pacing

The FDA awarded Medtronic the first and only approval for a conduction system pacing device with an extended label Oct. 17. 

The conduction system pacing approach "helps ensure that pacing closely mimics the heart's physiologic contractions, allowing the heart's ventricles to work in coordination," the company said in a news release. 

2. Medtronic offers hospitals free, unapproved backup controller for recalled HVAD systems

In response to the recall of thousands of heart pumps that's been linked to more than 3,000 deaths, Medtronic said a backup controller with modified software, which isn't approved, is available for free to eligible hospitals. 

In an Oct. 13 medical device correction letter, Medtronic said if the heart pump has stopped and if the primary controller isn't working, hospitals can request a backup controller to help restart the pump. 

"While the software is currently unapproved and there is very limited testing completed, some patients may have no alternative options for support if the standard controller fails to restart the pump," Medtronic said in the letter. 

A congressional subcommittee is currently investigating how the FDA handled the recall of Medtronic's HeartWare Ventricular Assist Devices.

Copyright © 2023 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars