Claris Law Legal Blogging Community

Name:

E-mail:

Phone Number:

Zip Code:

Your Question:

Editor: Marc Jay Bern
Profession: Defective Medical Device Lawyer

Category: Medtronic News

A new pacemaker made by Medtronic medical device maker has been deemed safe for use in MRI scans, according to recently released efficacy data.

The EnRhythm MRI SureScan Pacing System device is the first of its kind designed to work safely in patients inside MRI machines, which are commonly used to diagnose certain types of cancer and neurological disorders.

In Europe, some two million people have pacemakers, but are restricted from receiving MRI scans because the devices can malfunction by interacting with the scanner.

The new device offers a solution for up to 50 percent of patients worldwide with implanted cardiac devices, which are expected to require an MRI scan at some point.

The promising study findings pave the way for Medtronic to seek approval for SureScan in markets beyond that of the United States. Some analysts say U.S. approval could be as soon as 2009.