FDA approves Biotronik Eluna pacemaker system with full-body ProMRI technology


Biotronik has announced that the Food and Drug Administration (FDA) has approved its ProMRI Eluna pacemaker system. The company’s ProMRI technology allows patients to undergo full-body magnetic resonance imaging (MRI) scans with both single-chamber and dual-chamber Eluna pacemakers when implanted with Setrox pacing leads.

“Due to safety concerns, most pacemakers are currently not approved for use in the MRI environment, limiting patients’ treatment options,” says Theofanie Mela, electrophysiologist at Massachusetts General Hospital in Boston, USA, and investigator for the Biotronik ProMRI study. “MR conditional systems are necessary, and giving patients better access to diagnostic options will allow for better treatment.”

Until recently, patients with a pacemaker or ICD were denied MRI scans due to concern that the strong magnetic fields and radio waves created by an MRI scanner could have a negative effect on both the implanted device and the patient.

Biotronik Home Monitoring is available with Eluna pacemakers.