Medtronic has obtained approval from the US Food and Drug Administration (FDA) to commercialise its new Azure pacemakers available in single and dual chamber models.
Claimed to provide improved longevity to lower the need for replacements, the Azure XT and Azure S pacemakers enable scanning of patients in 1.5 or 3 Tesla (T) MRI machines.
The devices feature the firm’s BlueSync technology designed for automatic, secure, wireless and remote monitoring of patients through Medtronic CareLink Network.
Medtronic Reactive atrial-based antitachycardia pacing (ATP) algorithm is additionally integrated into the Azure XT pacemaker to potentially slow the progression of atrial fibrillation (AF).
Medtronic senior vice-president and Cardiac Rhythm and Heart Failure division president John Liddicoat said: “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.”
The remote monitoring and automatic data transmission capabilities of the Azure pacemakers are expected to aid in early clinical decisions and better patient compliance.
Following the FDA approval, Medtronic has also included the BlueSync technology in its Percepta portfolio of quadripolar, MR-conditional cardiac resynchronisation therapy pacemakers (CRT-Ps) to remotely monitor patients through the CareLink Network.
Earlier this month, the firm obtained CE-Mark for its Intellis platform developed to stimulate spinal cord and peripheral nerves for the management of certain types of chronic pain.
The fully implantable neurostimulator can be used to continuously record and track patient activity.