Devices & Diagnostics

Medtronic pacemaker impervious to MRIs wins FDA approval

Medtronic (NYSE:MDT) received U.S. Food and Drug Administration approval for its Revo MRI SureScan. The pacemaker is the first that isn’t effected by MRI scans and Medtronic says it will begin shipping the new innovative medical devices immediately. About 200,000 people with pacemakers can’t get MRI scans because of potential problems.

By MassDevice Staff on February 08, 2011

The Food & Drug Administration approved Medtronic Inc.’s (NYSE:MDT) MRI-safe pacemaker, touted as the first such device to hit the market.

The Minneapolis-based medical device giant said it plans to begin shipping the product immediately.

The Revo MRI SureScan pacing system is the “first and only pacemaker system in the U.S. specifically designed for use in an magnetic resonance imaging environment,” according to the company.

An FDA advisory panel recommended that the agency approve the device in March of last year.

About 200,000 people implanted with pacemakers must forego MRI scans every year in the U.S. because of the danger of serious adverse events. The magnetic field from the MRI machine can disrupt a pacemaker’s ability to function and regulate the patient’s heartbeat. Prior to an MRI scan, a patient implanted with a Revo pacemaker must have it programmed to withstand the magnetic energy, according to the company.

There are about 5 million people worldwide implanted with pacemakers and implantable cardioverter-defibrillators, according to Medtronic, while there are about 30 million MRI scans per year.