FDA OKs pacemaker that allows for MRI scans

The FDA approved a pacemaker system that allows patients with single-chamber pacemakers to undergo full-body cardiac or thoracic MRI scans.

Berlin-based Biotronik announced March 20 that its ProMRI Eluna, designed for patients with single-chamber and dual-chamber Eluna pacemakers implanted with Setrox pacing leads, received FDA approval.

The approval adds to the company’s portfolio of MRI-compatible devices and leads.  Last year the FDA approved the Entovis pacemaker system with ProMRI technology, which allows for imaging with a limited exclusion zone.