Biotronik said today that it won CE Mark approval in the European Union for its Edora line of MRI-adaptable pacers.
The German medical device company said the Edora pacemakers and cardiac resynchronization therapy pacemakers use a sensor called MRI AutoDetect that’s designed to ensure that the device goes into safe mode only during magnetic resonance scans, ensuring that the device continues to deliver therapy for as long as 14 days after the sensor is activated. Once the scan is over, the Edora device automatically resumes therapy without needing to be reset by a physician, Biotronik said.
“The MRI AutoDetect feature recently won the Cardiostim Innovation Award for ‘Best Practice Improvement,’ in recognition of our contribution to patient safety and easing physician workflows. With Edora’s approval, we are the first to offer MRI AutoDetect to all device patients, whether they are pacemaker, ICD, or CRT patients,” senior vice president Manuel Ortega said in prepared remarks. “With home monitoring and the closed-loop stimulation algorithm also on board, we’re proud to be able to give all patients, whatever device they need, the very best care possible.”
“MRI compatibility for cardiac devices has been a critical development in helping our patients to have longer, better lives. But there are still logistical challenges to managing workflow between cardiologists and radiologists. MRI AutoDetect will certainly help to simplify those,” added Dr. Paul Foley of the Great Western Hospital in Swindon, England. “Meanwhile, reducing the amount of time the device is in MRI mode helps to minimize both the risk to the patient and the impact on their quality of life. This is because the pacemaker functions with all its available features for as long as possible before the scan begins.”