FDA OKs Medtronic pacemaker for MRI

Interventional device developer Medtronic has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Advisa MRI SureScan pacemaker.

Advisa is Medtronic's second-generation MR-conditional pacemaker, following the company's first-generation Revo MRI SureScan system. It combines enhanced pacing technology with MRI compatibility, according to the firm. Medtronic expects to begin marketing Advisa immediately.

As many as 75% of patients with implanted cardiac devices worldwide could need an MRI scan during their device's lifetime, according to the company.