BIOTRONIK Secures FDA Approval for Next-Generation Pacemaker Lineup

Friday, July 07, 2023

BIOTRONIK has announced that its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P) has received approval from the U.S. Food and Drug Administration (FDA). This approval represents the latest advancement in cardiac rhythm management from BIOTRONIK. The Amvia Edge pacemakers, known for being the market's smallest single-chamber MR conditional pacemakers, introduce patient-centric clinical solutions and automated workflow efficiency.

One notable feature of the Amvia Edge pacemakers is the inclusion of BIOTRONIK's proprietary MRI Guard 24/7 technology. This technology utilizes dedicated sensors that are always active to automatically detect when a patient enters an MRI field and switch the device to MRI mode. Once the MRI scan is complete, the device seamlessly returns to its permanent programming, eliminating the need for pre- or post-scan programming.

Dr. David Hayes, Chief Medical Officer at BIOTRONIK, emphasized the significance of MRI Guard 24/7, stating that it addresses real-world challenges and aims to improve safety and efficiency for patients with cardiac implantable electronic devices (CIEDs) who require access to MRI. The goal is to make the MRI scanning process as convenient as possible for patients while minimizing any discomfort.

Additionally, the Amvia Edge pacemakers feature Atrial ATP (aATP) technology, which automatically delivers multiple therapies in response to stable atrial arrhythmias. This can help reduce the burden of atrial tachycardia and potentially prevent atrial remodeling. Atrial tachycardia carries risks such as an increased risk of stroke and heart failure, as well as a decrease in the patient's quality of life. Alongside its MRI compatibility and atrial arrhythmia solutions, the Amvia Edge series offers new tools that automate essential tasks, including pre-discharge checks. The EarlyCheck feature automatically sends a device report and IEGM data to the Home Monitoring Service Center two hours after implantation, eliminating the need for in-person device interrogation.

Ryan Walters, President of BIOTRONIK, expressed the company's commitment to healthcare professionals, stating that Amvia Edge demonstrates their ongoing dedication to supporting healthcare professionals in providing the best possible care for their patients. The series' clinical treatment options and built-in efficiencies are designed to address the everyday challenges faced by patients, physicians, and caregivers.

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