Abbott (Abbott Park, IL) announced that the U.S. Food and Drug Administration (FDA) has approved the company’s next-generation Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices.
The Bluetooth-enabled devices bring new benefits to patients with heart rhythm disorders, “including a patient-preferred design without compromising battery longevity and MRI compatibility,” Abbott says.
The new Gallant system pairs with Abbott’s secure myMerlinPulse, an iOS- and Android-compatible mobile smartphone app that helps streamline communication between doctors and their patients.
Through the myMerlinPulse app, physicians can continuously monitor their patients remotely allowing for identification of asymptomatic episodes as well as patient-triggered transmissions, which can lead to earlier intervention and reduce clinical burden, the company says.
The Gallant system received CE Mark for use across Europe earlier this year.