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

Related Content

Study Unveils Brain Changes During Extended Space Missions
News | Neuro Imaging | November 14, 2017
November 14, 2017 — More people today are poised to explore space than ever before; those who do will experience the
Synthetic CT Images Suitable for Prostate Cancer Radiotherapy Planning
News | Treatment Planning | November 14, 2017
Spectronic Medical announced that new data for their MRIPlanner software, generating synthetic computed tomography (sCT...
News | Magnetic Resonance Imaging (MRI) | November 13, 2017
Aspect Imaging announced last week that it received CE marking for the neonatal-dedicated Embrace Neonatal Magnetic...
Hitachi Healthcare Highlights Benefits of High-Field Open MRI in New Supplement

Click here to view the supplement.

News | Magnetic Resonance Imaging (MRI) | November 13, 2017
A new 24-page publication from Hitachi Healthcare details the benefits of High-Field Open MRI and is now available for...
Siemens Healthineers Introduces Share360 Tailored Service Portfolio
News | Imaging | November 10, 2017
November 10, 2017 — To address the specific needs of...
Johns Hopkins Researchers, Carestream Give Presentations on Medical Imaging Advances at RSNA
News | Digital Radiography (DR) | November 09, 2017
November 9, 2017 — Researchers from The Johns Hopkins University School of Medicine and Carestream Health scientists
3D CT image reconstruction of the thoracic organs and the heart using Philips software.
Sponsored Content | Webinar | Advanced Visualization | November 07, 2017
The CME webinar “Innovation and Success in 3D-inspired Development of the Business and Clinical Practice,” will take
Post-Concussion Brain Changes Persist for Pre-Teen Hockey Players
News | Magnetic Resonance Imaging (MRI) | November 02, 2017
Young hockey players who have suffered concussions may still show changes in the white matter of the brain months after...
Siemens Healthineers Announces First U.S. Installation of Magnetom Vida 3T MRI Scanner
News | Magnetic Resonance Imaging (MRI) | November 02, 2017
Mallinckrodt Institute of Radiology at Washington University School of Medicine, St. Louis, recently became the first U...
Football Position and Length of Play Affect Brain Impact
News | Magnetic Resonance Imaging (MRI) | October 31, 2017
Researchers have found that damage to white matter in the brains of former college and professional football players...
Overlay Init