FDA approves next-generation pacemakers with automatic MRI field detection sensors
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Key takeaways:
- The FDA approved pacemakers with automatic MRI field sensing functionality.
- This feature is designed to streamline the MRI workflow for patients with these pacemakers.
Biotronik announced the FDA approved its portfolio of pacemakers and cardiac resynchronization therapy pacemakers featuring automatic MRI detection designed to streamline MRI workflow.
The pacemakers (Amvia Edge) feature proprietary sensors dedicated to automatically recognize when a patient enters an MRI field, converts the device to MRI mode and returns to its permanent programming after scan completion, according to a company press release.
Image: Adobe Stock
"MRI Guard 24/7 is a solution for real-world challenges, as we strive to improve safety and increase efficiencies for [cardiac implantable electronic device] patients who need MRI access," David Hayes, MD, FACC, chief medical officer of Biotronik, said in the release. "An MRI scan should be as easy as possible for patients, but also for caregivers in the device clinic and the MRI suite. MRI Guard 24/7 avoids repeat visits to the clinic for pre- and post-programming, and because the device only switches to MRI mode during the scan itself, it minimizes any potential patient discomfort."
The pacemakers also feature atrial antitachycardia pacing as well as pre-discharge checks (EarlyCheck) which automatically generate a device report and intracardiac electrograms 2 hours after implant, eliminating need for in-person device interrogation, according to the release.
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