Biotronik said today that the FDA approved its ProMRI Eluna MRI-safe pacemaker, making it the only company with single- and dual-chamber MRI-safe pacemakers on the U.S. market.
Lake Oswego, Ore.-based Biotronik said the approval covers the single- and dual-chamber Eluna devices and Setrox leads for full-body MRI.
"We want every pacemaker patient to know that they can access MRI scans with our tested and approved systems," sales & marketing executive vice president Paul Woodstock said in prepared remarks. "Biotronik’s latest device and ProMRI technology ensure that patients – and their physicians – will have the best diagnostic options available."
"Due to safety concerns, most pacemakers are currently not approved for use in the MRI environment, limiting patients’ treatment options," added Dr. Theofanie Mela of Boston’s Mass. General Hospital, an investigator for Biotronik’s ProMRI study. "MR conditional systems are necessary, and giving patients better access to diagnostic options will allow for better treatment."
In November 2014, the company paid $5 million to settle federal allegations that it used kickbacks to induce doctors to use its cardiac rhythm-management devices.