The Sorin Group said it has received regulatory approval in Japan for a new MRI-compatible pacemaker.
The country's Pharmaceuticals and Medical Devices Agency (PMDA) approved Sorin's Kora 100 pacing system with automatic MRI mode.
MRI-compatible pacemakers are highly desirable in Japan because the elderly population in which they are typically implanted is prone to medical conditions that require MRI for optimal diagnosis and management, Sorin said. When implanted with the company's Beflex pacing leads, patients with Kora 100 SR and DR pacemakers can safely undergo MRI exams.
Kora 100 automatically adjusts its settings when it detects an MRI field, eliminating the need for manual adjustment. This also reduces the amount of time patients spend in asynchronous mode, lowering their chance of cardiac arrhythmias, according to the company.
