Sorin receives CE mark for its Kora 100, a new MRI compatible pacing system


Sorin has announced the CE mark approval and first implant of the Kora 100 pacing system. Kora 100 SR and DR pacemakers when implanted with the Sorin Beflex pacing lead, according to a company release, enable implanted patients to undergo magnetic resonance imaging (MRI) safely.

The system allows safe operation during an MRI examination. The device also senses when a patient leaves the MRI field, and return to normal operation within five minutes. The Automatic MRI Mode feature, which is patented and available exclusively on Sorin Group pacemakers, according to a company release, limits the amount of time that Kora 100 pacemakers operate in MRI mode.

Christian Wollmann, cardiologist at Landesklinikum St Pölten, Austria, implanted the first Kora 100 in a 79-year old man. Harald Mayr, head of the Cardiology department at St Pölten, commented: “The Kora 100 pacing system with the Automatic MRI Mode provides benefits to our patients, the cardiology practice, and to my colleagues in radiology. Because the pacemaker only operates in MRI mode during the actual MRI procedure, I can be more flexible in scheduling my pre-MRI visits. Since the pacemaker automatically switches back to the pre-programmed settings without further intervention, the radiologists can be confident about patient safety after the imaging procedure.”

The Kora 100 pacing system manages common cardiovascular co-morbidities such as sleep apnoea, atrial fibrillation and heart failure. The SafeRTM 2 pacing mode has been clinically proven to nearly eliminate deleterious left ventricular pacing thus reducing the risk of atrial fibrillation. The recently introduced Sleep Apnoea Monitoring (SAM) function, is a clinically validated, easy-to-use diagnostic algorithm designed to screen and monitor severe sleep apnoea, a significant co-morbidity related to heart failure.

“The Kora 100 with Sorin’s proprietary SafeR algorithm, sleep apnea monitoring, and the patented automatic MRI mode is the clear gold standard in pacing technology today. We are very proud to launch this latest innovative technology from Sorin Group,” said Stefano Di Lullo, Sorin Group, president CRM Business Unit.