Biotronik gets FDA approval for ProMRI Eluna pacemaker system

22 March 2015 (Last Updated March 22nd, 2015 18:30)

The US Food and Drug Administration (FDA) has granted approval for German cardiovascular devices manufacturer Biotronik's ProMRI Eluna pacemaker system.

The US Food and Drug Administration (FDA) has granted approval for German cardiovascular devices manufacturer Biotronik's ProMRI Eluna pacemaker system.

The company said 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.

Patients with single-chamber pacemakers have not been able to access cardiac or thoracic MRI scans before. In the US, Biotronik is the only firm with a complete portfolio of pacemakers approved for use with all 1.5 T MRI scans.

Investigator for the Biotronik ProMRI study Dr Theofanie Mela said: "Due to safety concerns, most pacemakers are currently not approved for use in the MRI environment, limiting patients' treatment options.

"MR conditional systems are necessary, and giving patients better access to diagnostic options will allow for better treatment."

"There are currently more than 6.5 million pacemaker patients worldwide, with an additional million patients receiving new implants each year."

There are currently more than 6.5 million pacemaker patients worldwide, with an additional million patients receiving new implants each year.

Patients with a pacemaker or ICD were denied MRI scans due to concerns 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.

The company's Home Monitoring, which is available with Eluna pacemakers, allows physicians to efficiently deliver the highest level of patient care by managing their patients' status through early detection of clinical episodes and device events.

Biotronik sales and marketing executive vice-president Paul Woodstock said: "We want every pacemaker patient to know that they can access MRI scans with our tested and approved systems.

"Biotronik's latest device and ProMRI technology ensure that patients and their physicians will have the best diagnostic options available."

The company offers the only automatic, daily remote monitoring system for MR conditional pacing systems.