Medtronic Wins Approval for MRI-Safe Pacemaker

Medtronic Inc said it received U.S. Food and Drug Administration approval for the first heart pacemaker that can safely be used during magnetic resonance imaging exams.

The company said it will begin shipping the product, called Revo MRI, immediately.
Pacemakers are surgically implanted devices that generate electrical impulses to treat stalled heartbeats.

About 200,000 pacemaker patients a year do not receive an MRI for a health diagnosis because of the potential for the machine's magnetic fields to interfere with pacemaker operation, according to Medtronic.

The Revo pacemaker is among the new products analysts expect will help Medtronic re-accelerate growth in its cardiac rhythm management division.

Although FDA has approved the product, a warning letter regarding quality systems issues at Medtronic's Mounds View, Minnesota, manufacturing facility remains in place.

FDA spokeswoman Karen Riley said the agency approved the product's release despite the warning letter because the device "meets a significant public health need" and therefore its availability should not be delayed.

Medtronic spokeswoman Wendy Dougherty said the company continues to work with FDA toward final resolution of the warning letter.

About 5 million patients worldwide have received a pacemaker or an implantable cardioverter defibrillator. ICDs treat dangerously rapid heartbeats by providing a jolt of electricity to shock the heart back into normal rhythm.

Shares of Medtronic closed up 27 cents at $39.81 on the New York Stock Exchange on Tuesday.