FDA approves BIOTRONIK Eluna pacemaker

FDA approves BIOTRONIK Eluna pacemaker

Second generation single- and dual-chamber pacemakers that give patients access to MRI Scans now available in the US.

March 30, 2015
Manufacturing Group
Contract Manufacturing Devices/Implants/Equipment Industry/Regulations People/Facilities Design/Engineering

Lake Oswego, Oregon – BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the 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. BIOTRONIK is the only company in the US with a complete 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 Dr. Theofanie Mela, 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 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, the pioneer in wireless, remote monitoring for implantable cardiac devices, provides the only automatic, daily remote monitoring system for MR conditional pacing systems. BIOTRONIK Home Monitoring, 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.

“We want every pacemaker patient to know that they can access MRI scans with our tested and approved systems,” commented Paul Woodstock, BIOTRONIK executive vice president of sales and marketing. “BIOTRONIK’s latest device and ProMRI technology ensure that patients – and their physicians – will have the best diagnostic options available.”