FDA approves next generation Gallan implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. Abbott

Abbott announced that the FDA has approved the company’s next-generation Gallan™ implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices.

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. It is estimated that as many as 6.1 million people in the United States battle cardiac arrhythmias, or abnormal heart rhythms, and ICDs are used to help reduce the risks of life-threatening arrhythmias. For patients with heart failure or in situations when the heart’s chambers beat out of sync, CRT-Ds can be used to restore the heart’s natural pattern of beating.

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.

The Gallant system received CE Mark for use across Europe earlier this year.