European Regulators Approve Biotronik Pacemakers

Biotronik SE & Co. kg has announced CE Mark 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 magnetic resonance imaging (MRI) sensors. The small-sized Edora pacemakers are also expected to have more than 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.

“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,” commented Dr. Paul Foley, Great Western Hospital, Swindon, United Kingdom. “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.”

Edora single- and dual-chamber pacemakers currently have CE approval for full-body MRI scans at 1.5T and 3.0T scans with an exclusion zone.

“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,” said Manuel Ortega, senior vice president at Biotronik. “With Home Monitoring and the Closed Loop Stimulation algorithm also onboard, we’re proud to be able to give all patients, whatever device they need, the very best care possible.”

Biotronik ProMRI technology enables patients with a pacemaker, implantable defibrillator, cardiac monitor, or cardiac resynchronization therapy defibrillator (CRT-D) or pacemaker (CRT-P) to undergo an MRI scan. Devices with MRI AutoDetect have the additional capability of automatically recognizing an MRI environment within a programmable time window, switching on the device’s MRI mode for only as long as is required to complete the scan. This typically lasts around 30 minutes. This ensures the patient receives the full benefit of their device for the maximum amount of time possible.
 
Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore.