FDA approves pacemakers for bradycardia

Medtronic announced that a line of pacemakers for the treatment of patients with bradycardia has been approved by the FDA and has launched in the United States.

The pacemakers (Azure XT MRI, Azure S MRI; Medtronic) are available in single- and dual-chamber models. Both models have improved longevity, with the dual-chamber model lasting 27% longer than its predecessor, according to a press release from the company. Patients with the pacemakers may also undergo MRI scans in 1.5 T or 3 T machines.

Clinicians can review clinically relevant patient events through a secure wireless remote monitoring capability (BlueSync, Medtronic). The pacemakers also have a pacing algorithm (Reactive ATP, Medtronic), which has been shown to decelerate the progression of atrial fibrillation in the MINERA trial.

As Cardiology Today has previously reported, data from the MINERVA trial showed that this advanced pacing feature was linked to a decreased development and progression of persistent AF.

“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 of Medtronic and president of the cardiac rhythm and heart failure division, said in the press release. “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.”

Disclosure: Liddicoat is an employee of Medtronic.