The US Food and Drug Administration (FDA) has approved Biotronik’s Amvia Edge pacemaker portfolio and cardiac resynchronisation therapy pacemaker.
Amvia Edge is claimed to be the smallest single-chamber MR conditional pacemaker in the market.
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The next-generation pacemakers are equipped with the company’s MRI Guard 24/7 technology, which utilises always-on sensors for detecting automatically when a patient enters an MRI field and then transitions the device into MRI mode.
After completion of the scan, the device returns to its permanent programming to avoid pre or post-scan programming requirements.
The Amvia Edge devices also have Atrial ATP for delivering several, automatic therapies in response to identified stable atrial arrhythmia.
It helps lower the burden of atrial tachycardia besides avoiding atrial remodelling.
Amvia Edge has new tools for automating major tasks such as pre-discharge checks, in addition to its MRI and atrial arrhythmia solutions.
Two hours after implant, a device report and IEGM can be automatically sent to the Home Monitoring Service Centre using the EarlyCheck feature, for eliminating in-person device interrogation.
Biotronik president Ryan Walters said: “Amvia Edge represents Biotronik ‘s continued commitment to healthcare professionals to help them serve their patients.
“The clinical treatment options and built-in efficiencies of Amvia are designed to solve everyday challenges for patients, physicians and caregivers.”
Last month, Biotronik announced the first global implant of its BIOMONITOR IV implantable cardiac monitor with artificial intelligence.
