FDA approved Medtronic's Azure pacemakers, which feature the company's new BlueSync technology to protect patients from having their device hacked. The BlueSync technology is also now available with the Medtronic Percepta portfolio of quadripolar, MR-conditional cardiac resynchronization therapy pacemakers (CRT-Ps), the company said. BlueSync is intended to enable more secure wireless remote monitoring via Medtronic's CareLink Network, by limiting access to the device functionality and also by protecting patient data.
Connected medical devices like pacemakers add value to patient care by enabling remote patient monitoring and giving clinicians access to important patient data that can result in more timely care. But these devices also present new cybersecurity vulnerabilities that could put patients at risk. That's why experts are adamant that cybersecurity must be part of medical device architecture.
Awareness of cybersecurity issues is no longer the problem in the medical device field, but many companies are still unprepared to handle a cybersecurity incident, according to a recent industry poll.
In addition to the benefits of BlueSync technology, Medtronic said its new Azure pacemakers offer improved longevity, estimated at 13.7 years, which is about 27%, longer than its predecessor. The company launched both a single chamber and dual chamber model of the device, the Azure XT MRI and Azure S MRI. And as the name suggests, both devices allow patients to have MRI scans.
The Azure XT pacemaker features the Medtronic Reactive ATP (atrial-based antitachycardia pacing) algorithm, which was shown in the MINERVA trial and real-world studies to slow the progression of atrial fibrillation (AF) in patients with implanted cardiac devices.
"With the approval of Azure, clinicians managing patients with bradycardia now have pacemakers with improved longevity, and [a] better ability to detect and reduce atrial fibrillation," said John Liddicoat, MD, president of Medtronic's cardiac rhythm and heart failure division. "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."