Technology | March 23, 2015

FDA Approves Biotronik Eluna Pacemaker System with Full-Body ProMRI Technology

Single- and dual-chamber pacemakers give patients access to MRI scans

Biotronik, Eluna, ProMRI, FDA

March 23, 2015 — Biotronik announced that the U.S. Food and Drug Administration (FDA) has approved its ProMRI Eluna pacemaker system. Biotronik ProMRI technology allows patients to undergo full-body magnetic resonance imaging (MRI) scans with both single-chamber (SR-T) and dual-chamber (DR-T) Eluna pacemakers when implanted with Setrox pacing leads.

Until now, patients with single-chamber pacemakers have not been able to access cardiac or thoracic MRI scans. The Eluna joins Biotronik’s portfolio of pacemakers approved for use with all 1.5 T MRI scans. Magnetic resonance imaging improves diagnostic capabilities for many medical conditions like chronic neck or lower back pain, soft tissue masses and stroke symptoms that cannot be adequately examined by X-ray or computerized tomography (CT).

“Due to safety concerns, most pacemakers are currently not approved for use in the MRI environment, limiting patients’ treatment options,” said Theofanie Mela, M.D., electrophysiologist at Massachusetts General Hospital in Boston, Massachusetts, 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.”

There are more than 6.5 million pacemaker patients worldwide, with an additional million patients receiving new implants each year. Until recently, patients with a pacemaker or implantable cardioverter defibrillator (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.

Eluna pacemakers are available with Biotronik Home Monitoring, which allows physicians to manage their patients’ status through early detection of clinical episodes and device events.

For more information: www.biotronik.com

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