Biotronik Edora pacemakers receive CE mark approval


Biotronik has received CE mark approval for its new Edora pacemakers and cardiac resynchronisation therapy pacemakers (CRT-Ps).

Edora devices feature the Biotronik’s ProMRI (magnetic resonance imaging) technology, including the MRI AutoDetect sensor. According to a company release, the Edora pacemakers are also expected to have upwards of 14 years of longevity.

MRI AutoDetect is designed to simplify physician workflow and to 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. According to the release, 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 should then receive a full report via Biotronik home monitoring within 24 hours of the scan.

“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,” comments Paul Foley, Great Western Hospital, Swindon, UK. “Meanwhile, reducing the amount of time the device is in MRI mode helps to minimise 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.”

“The MRI AutoDetect feature recently won the Cardiostim Innovation Award for ‘Best Practice Improvement’,” states Manuel Ortega, senior vice president at Biotronik.

Edora single- and dual-chamber pacemakers currently have CE marking for full-body MRI scans at 1.5T and 3T scans with an exclusion zone.