World’s Smallest Single-Chamber MR Conditional Pacemaker Streamlines MRI Workflow

Historically, individuals with a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device were unable to undergo magnetic resonance imaging (MRI) due to these devices' lack of approval for MRI scanning and the untested effects of MRI on ICDs. A new generation of pacemakers now integrates an always-on, automatic MR detection algorithm to significantly streamline the MRI workflow.

BIOTRONIK’s (Berlin, Germany) portfolio of Amvia Edge line of pacemakers and CRT pacemakers marks its latest innovation in cardiac rhythm management. The Amvia Edge, the smallest single-chamber MR conditional pacemaker available, combines patient-centric clinical solutions with automated workflow efficiency. The device integrates BIOTRONIK's unique MRI Guard 24/7 technology, which utilizes always-on, dedicated sensors that automatically detect the patient's entry into an MRI field, subsequently switching the device to MRI mode. Once the scan is complete, the device reverts to its original programming, eliminating the need for pre- or post-scan programming.

Additionally, all Amvia Edge devices incorporate Atrial ATP (aATP), offering multiple automatic therapies in response to stable atrial arrhythmias. This feature could reduce the burden of atrial tachycardia and help prevent atrial remodeling. Atrial tachycardia can increase the risk of stroke and heart failure, consequently reducing the quality of life. Alongside its MRI and atrial arrhythmia solutions, Amvia Edge introduces new tools that automate key tasks, such as pre-discharge checks. The EarlyCheck feature allows a device report and IEGM to be automatically dispatched to the Home Monitoring Service Center two hours post-implant, eliminating the requirement for in-person device interrogation. BIOTRONIK's Amvia Edge pacemakers and CRT-P portfolio has been approved by the U.S. Food and Drug Administration (FDA).

"MRI Guard 24/7 is a solution for real-world challenges, as we strive to improve safety and increase efficiencies for CIED patients who need MRI access," said Dr. David Hayes, Chief Medical Officer, BIOTRONIK, Inc. "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."

"Amvia Edge represents BIOTRONIK's continued commitment to healthcare professionals to help them serve their patients," said Ryan Walters, President, BIOTRONIK, Inc. "The clinical treatment options and built-in efficiencies of Amvia are designed to solve everyday challenges for patients, physicians, and caregivers."

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