Biotronik AG landed CE Mark approval in the European Union for what it calls the world’s first and only implantable defibrillator with clearance for use with MRIs.
The Berlin-based company announced the implantation of the Lumax 740 in patients in several European countries after winning regulatory approval last week.
The new generation implantable cardiac defibrillators are fitted with a ProMRI feature that protects them from interference with magnetic resonance imaging machines. The device also boasts 11-year longevity, according to a press release.
Magnetic fields used in MRIs have the potential to disrupt cardiac implant functions and keep them from properly regulating a patient’s heart rhythms.
"Until now, patients with an ICD had been excluded from undergoing MR scans despite the fact that these scans are critical for the diagnosis and therapy of patients with serious medical conditions, such as cancer, stroke and other neurologic and orthopedic conditions," World Society of Arrhythmias president Professor Massimo Santini said in prepared remarks. "The ability to use MR scans is extremely important and will become even more important in the future. MR scans deliver superior imaging quality and do not require any exposure to radiation. Hence, the Lumax 740 is really a device for the future."
Biotronik is also testing another new feature with the Lumax 740 series, an intracardiac impedance assessment technology designed to enhance therapy for heart failure patients in the future.
The device joins another recent first: Medtronic Inc.’s (NYSE:MDT) Revo MRI SureScan pacemaker, the first pacing system designed with MRIs in mind.
There are about 5 million people worldwide implanted with pacemakers and implantable cardioverter-defibrillators, according to Medtronic, while there are about 30 million MRI scans per year.