Medical device giant Medtronic (NYSE:MDT) won FDA approval for its Advisa DR MRI SureScan pacing system, planning to launch commercial efforts immediately.

The pacemaker’s SureScan technology allows patients to receive MRI scans that normally pose a threat to traditional pacemaker function and patient safety.

"The Advisa MRI system is Medtronic’s second-generation MR-Conditional pacemaker and is the 1st system to combine the most advanced pacing technology with proven MRI access," according to a press release.

The Minnesota medical device maker has been touring its MRI-safe implants in the European Union and in Japan. Euro regulators recently approved Medtronic’s neurostimulation implants for compatibility with full-body MRI scanning.

The FDA in 2001 granted Medtronic approval to begin testing its MRI pacemaker technology through a study of up to 250 patients across 50 centers in Europe, Central Asia, the U.S., Canada and Australia.

"MRI is just so very important and traditional pacemakers not FDA approved for MRI scanning often prevent the patient from having an MRI when they need it," Tennessee physician Dr. J. Rod Gimbel said on behalf of the company. "With more than 85% of pacemaker patients being at least 65 years old and having multiple comorbidities for which MRI may be needed, it’s key that physicians and patients have a pacing system that allows MRI imaging as a diagnostic procedure."

The 1st SureScan pacemakers were introduced to the European market in 2008 and more than 10,000 such devices have been sold worldwide, according to a press release.