Sorin Group has obtained CE Mark approval for its KORA 100 pacing system, a new magnetic resonance imaging (MRI) compatible device.
The company also reported the first successful implant of KORA 100 pacing system at Landesklinikum St Pölten, Austria.
KORA 100 SR and DR pacemakers enable patients to undergo safe MRI scan when implanted with the Sorin BEFLEX pacing lead.
The KORA 100 pacing system with the Automatic MRI Mode has been designed with both patients and physicians in mind, the company reported.
Available exclusively on Sorin Group pacemakers, the patented Automatic MRI Mode feature limits the amount of time that KORA 100 pacemakers operate in MRI mode.
The device settings of KORA 100 pacemaker will automatically enable safe operation, whenever it detects the MRI scanner's magnetic field and it automatically switches to normal settings without further intervention in just five minutes once the patient leaves the MRI field.
The KORA 100 pacing system features proprietary Sorin's proprietary SafeR algorithm, Sleep Apnea monitoring, and the patented Automatic MRI mode to help physicians manage common cardiovascular co-morbidities such as sleep apnea, atrial fibrillation and heart failure.
Currently available in DR pacemaker systems, the SafeR pacing mode has been clinically proven to nearly eliminate deleterious left ventricular pacing, reducing the risk of atrial fibrillation.
The recently introduced Sleep Apnea monitoring (SAM) function is a clinically validated, easy-to-use diagnostic algorithm, which is designed to screen and monitor severe sleep apnea, a significant co-morbidity related to heart failure.
Sorin Group CRM business unit president Stefano Di Lullo said: "We are very proud to launch this latest innovative technology from Sorin Group."
Image: Sorin's KORA 100 SR and DR MRI-compatible pacemakers. Photo: courtesy of Sorin Group.