Abbott’s Gallant implantable cardioverter defibrillator family of devices are capable of connecting patients and doctors via Bluetooth
Abbott has received the US Food and Drug Administration (FDA) approval for its Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices.
The health care company said that the new devices have been designed to prevent compromise in battery longevity and MRI compatibility, and benefit patients with heart rhythm disorders.
In addition, the new defibrillator devices would provide enhanced remote monitoring, improved patient or physician engagement and streamlined communications, by leveraging Bluetooth technology and a patient smartphone app
Abbott cardiac rhythm management senior vice president Randel Woodgrift said: “We are focused on developing and delivering life-changing technologies that impact patient care in a meaningful way.
“The Gallant devices are the latest example of how Abbott is driving innovation to meet changing healthcare needs and helping to improve connectivity and engagement between patients and their doctors.”
Gallant system received CE Mark approval in Europe this year
The company said that ICDs are used to help reduce the risks of life-threatening conditions in people with cardiac arrhythmias, or abnormal heart rhythms. CRT-Ds are used for patients with heart failure or when the heart’s chambers beat out of sync, to restore the heart’s natural pattern of beating.
Gallant system pairs with the company’s mobile smartphone app myMerlinPulse to facilitate communication between doctors and patients. The system has been granted CE Mark approval in Europe, earlier in 2020.
The mobile app provides users with access to data, device performance, and transmission history, helping them take an active role in their healthcare.
The myMerlinPulse app enables physicians to continuously monitor patients remotely, and allows identification of asymptomatic episodes, along with patient-triggered transmissions, which may lead to earlier intervention and reduce clinical burden.
Deborah Heart and Lung Center electrophysiology and pacing director Raffaele Corbisiero said: “The ability for patients to stay connected to their doctors via their implanted device and a smartphone app has the potential to change how healthcare providers and patients communicate with each other.
“The FDA’s approval of Abbott’s Gallant devices enables doctors to provide a more collaborative approach to treatment plans and the increased bond between a patient and provider will lead to better outcomes for all.”