Biotronik has announced CE approval for its new Edora pacemakers and cardiac resynchronization therapy pacemakers. Edora devices feature the company�s ProMRI technology, including the MRI AutoDetect sensor.
Biotronik has announced CE approval for its new Edora pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). Edora devices feature the company�s ProMRI technology, including the MRI AutoDetect sensor. This approval means that Biotronik now offers the industry�s first full portfolio of cardiac devices with MRI sensors.
The small-sized Edora pacemakers are also expected to have over 14 years of longevity. MRI AutoDetect helps to both simplify physician workflow and increase patient safety and quality of life by ensuring the patient�s device is in its MRI safe mode during only the period of the MRI scan itself. When a physician switches on the sensor, the device is calibrated to automatically adapt to an MRI environment, keeping the patient�s device at full functionality until the scan is performed. This can take place up to 14 days after the physician turns the sensor on. This 14-day period represents the longest programmable window for MRI sensors on the market. As soon as the scan concludes, the device restores automatically to full functionality, instead of the current procedure requiring manual reprogramming by the physician. The cardiologist receives a full report via Biotronik Home Monitoring within 24 hours of the scan.