Japanese Regulatory Approval for Sorin’s MRI Compatible Pacing System

Italian cardio device company Sorin Group, is celebrating approval from Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for its new KORA 100 pacing system with automatic magnetic resonance imaging mode (MRI mode) .

Background

We’ve covered, on many occasions now, the benefits of MRI compatibility of implantable devices such as pacemakers. In an increasingly elderly population the need for diagnostic MRI is only going to accelerate, all of which will ultimately make MRI compatibility a pre-requisite for newly implanted devices. During an MRI scan pacemakers need to operate in asynchronous mode which exposes the patient to potential cardiac arrhythmias. This mode usually needs to be programmed by a cardiologist prior to and after the MRI scan which leaves the patient in asynchronous mode for a longer period of time than required by the MRI scan itself.

Unlike other pacemakers, Sorin’s KORA 100 ensures that asynchronous mode is activated for the least amount of time. Once Auto MRI mode is activated, the KORA 100 automatically adjusts its settings when the MRI field is detected. This ensures the safe operation of the device during an MRI scan. The device senses when a patient leaves the magnetic field and returns to its initial operating mode within five minutes. The Automatic MRI mode feature is patented and available exclusively in Sorin Group pacemakers.

The KORA 100 pacing system will be distributed in Japan by Japan Lifeline Co., Ltd.

Company comments

“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 longevity6, will bring proven benefits to Japanese patients and physicians. Leveraging on our collaboration with our established business partner, Japan Lifeline, we will be able to achieve our market objectives and reinforce our leadership position,” said Stefano Di Lullo, Sorin Group, President CRM Business Unit.

Source: Business Wire

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