FDA Approves Azure Pacemaker Line

The US Food and Drug Administration (FDA) announced its approval of Medtronic’s Azure XT MRI and Azure S MRI pacemakers for the treatment of bradycardia.

Equipped with the company’s BlueSync technology, which allows for remote monitoring and alerts that can be viewed by the physician at any time, the pacemakers will also be commercially launched in the United States this month.

The Azure pacemakers are available in single and dual-chamber options, with an improved longevity of 27% compared to the Advisa MRI pacemaker. The dual-chamber model is estimated to have a 13.7-year span, allowing for fewer device replacements to be made.

The devices are safe to use in magnetic resonance imaging (MRI) scans, capable of utilization with 1.5 Tesla or 3 Tesla machines.

"With the approval of Azure, clinicians managing patients with bradycardia now have pacemakers with improved longevity, and better ability to detect and reduce atrial fibrillation" John Liddicoat, MD, senior vice president, Medtronic, and president of the Cardiac Rhythm and Heart Failure division, said in a statement. "BlueSync technology with Azure also enables secure and automatic wireless data transmission to clinicians. Remote monitoring with automatic data transmissions can result in earlier clinical decisions and improved patient monitoring compliance."

The pacemakers are also equipped with Medtronic’s Reactive atrial-based anti-tachycardia pacing (ATP) algorithm, which aides in the slowing of atrial fibrillation (AF) progression in patients with cardiac devices, as shown by the data from the phase 3 MINERVA trial, as well as supplemental data from real-world studies.

The data showed that the ATP algorithm reduced the incidence of persistent AF by 58% and a reduction of AF-related hospitalizations and emergency department visits by 52% (P <.001).