The Sorin Group announced it has received CE Mark approval for its MRI compatible KORA 100 SR and DR pacing systems, one of which has been successfully implanted in a 79-year-old man. When an MRI instrument begins scanning, the KORA 100 is able to detect the magnetic field that passes through the tissue, and switches to Automatic MRI Mode with the Sorin BEFLEX pacing lead, reducing risk of tachycardia.The system also detects when the MRI scan is complete and resumes its normal operating mode within 5 minutes.
The KORA 100 also features other proprietary Sorin technologies, including SafeR to monitor left ventricular pacing and minimize risk of atrial fibrillation, and Sleep Apnea Monitoring (SAM) to observe severe sleep apnea.
From the press release:
Dr. Christian Wollmann, cardiologist at Landesklinikum St. Pölten, Austria, implanted the first KORA 100 in a 79-year old man. Dr. 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.