The clearances cover both the Azure XT MRI and Azure S MRI pacers including single chamber and dual chamber models, the Fridley, Minn.-based company said. The newly cleared pacers have estimated lifespans of 13.7 years for dual chamber pacers, which Medtronic estimates is 27% longer than the earlier-gen devices.
The Azure portfolio of pacers feature the company’s BlueSynch technology which allows for automatic remote monitoring through the company’s CareLink network, and its Azure XT device features the Reactive ATP algorithm intended to slow the progression of atrial fibrillation.
“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. 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,” cardiac rhythm & heart failure division prez Dr. John Liddicoat said in a press release.
Medtronic said that in connection with the approval, its Percepta line of cardiac resynchronization therapy pacers now include BlueSync tech for remote monitoring through the CareLink network.
Earlier this month, Medtronic released its preliminary second quarter earnings, estimating the impact of Hurricane Maria at approximately $55 to $65 million, or 3¢ on its second quarter non-GAAP earnings per share.