Abbott today announced that the FDA has approved its next-generation Gallant™ line of ICD and CRT-D devices. According to the announcement:
“The devices bring new benefits to patients with heart rhythm disorders, including a patient-preferred design without compromising battery longevity and MRI compatibility. In addition, the new devices offer Bluetooth technology and a new patient smartphone app for improved remote monitoring, allowing for increased patient/physician engagement and streamlined communications.
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. The app provides people with access to data, device performance, and transmission history, which helps them take an active role in their healthcare. 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.”
Abbott received the CE Mark for these devices back in February 2020.