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.
