Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has granted approval for medical device firm Sorin Group’s new KORA 100 pacing system with automatic magnetic resonance imaging mode (MRI mode).
According to the company, KORA 100 SR and DR pacemakers helps patients implanted with Sorin BEFLEX pacing lead, to undergo MRI scan safely.
Sorin Group CRM business unit president 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."
The KORA 100 pacing system automatically adjusts its settings when the MRI field is detected, once auto MRI mode is activated. It allows the safe operation of the device during an MRI scan.
In addition, the device holds the capacity to sense when a patient leaves the magnetic field and returns to its initial operating mode within five minutes.
The new system was based on Sorin’s legacy of proactively managing common cardiovascular comorbidities, and the clinical results of the Answers study show that the SafeR pacing mode results in a 51% risk reduction of cardiac death or HF hospitalization.
Japan Lifeline will distribute the KORA 100 pacing system in the country.
Sorin said that the automatic MRI mode feature is patented and available exclusively in its pacemakers.
The company develops and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders.
Image: Right atrial and right ventricular leads as visualized under X-ray during a pacemaker implant procedure. Photo: courtesy of Gregory Marcus, MD, MAS, FACC.