Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has approved Sorin Group’s new KORA 100 pacing system with automatic magnetic resonance imaging (MRI) mode.
Pacemakers are implanted in elderly patients, a population prone to other medical conditions that require MRI examinations for optimal diagnosis and management.
The company said that KORA 100 SR and DR pacemakers allow implanted patients with Sorin BEFLEX pacing lead to safely undergo an MRI scan.
During an MRI scan, pacemakers should be operated in asynchronous mode, which exposes the patient to potential cardiac arrhythmias, while this procedure needs to be programmed by a cardiologist prior to and after the MRI scan.
Sorin Group president CRM business unit Stefano Di Lullo said: "The regulatory approval of our next-generation pacemaker marks a significant milestone for Sorin Group in Japan where there is strong demand for MRI compatible medical devices.
"We believe that KORA 100 with its unique automatic MRI mode, combination of therapeutic solutions, small size and extended longevity, will bring proven benefits to Japanese patients and physicians."
Compared to other pacemakers, the KORA 100 ensures that asynchronous mode is activated for the least amount of time.
KORA 100 pacing system automatically adjusts its settings when the MRI field is detected, once it is activated in auto MRI mode.
In addition, the system senses when a patient leaves the magnetic field and returns to its initial operating mode within five minutes.
The company’s business partner, Japan Lifeline, will be responsible for distributing the KORA 100 pacing system in Japan. The automatic MRI mode feature is patented and available exclusively in its pacemakers.