FDA approves Azure pacemakers with improved longevity. - Medtronic Inc.

Medtronic plc has announced FDA approval and U.S. commercial launch for its portfolio of Azure pacemakers with BlueSynctechnology. Available in both single chamber and dual chamber models, the Azure XT MRI and Azure S MRI pacemakers offer improved longevity, estimated at 13.7 years (dual chamber) or 27 percent longer than its predecessor, so patients likely need fewer device replacements. The new pacemakers also allow patients to have MRI (magnetic resonance imaging) scans in either 1.5 or 3 Tesla (T) machines.

In tandem with the approval of these new pacemakers, the Medtronic Percepta portfolio of quadripolar, MR-conditional cardiac resynchronization therapy pacemakers (CRT-Ps) also now includes BlueSync technology for secure, wireless remote monitoring via the Medtronic CareLink Network.

Azure pacemakers feature Medtronic-exclusive BlueSync technology, which enables automatic, secure wireless remote monitoring via the Medtronic CareLin Network, providing timely alerts of clinically relevant patient events that can be reviewed by a clinician at any time. Security controls implemented and validated on BlueSync enabled devices include access restrictions to protect integrity of device functionality and end-to-end encryption to protect patient data..