Abbott has received the US Food and Drug Administration (FDA) approval for its next-generation Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices.
With a patient-preferred design that offers battery longevity and MRI compatibility, the new devices are developed to benefit patients with heart rhythm disorders.
In addition, the new defibrillator devices are designed to use Bluetooth technology and a new patient smartphone app to provide enhanced remote monitoring, improved patient or physician engagement and streamlined communications.
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 pairs with Abbott’s secure myMerlinPulse mobile smartphone app
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.
The Gallant system works in combination with the company’s secure myMerlinPulse, an iOS- and Android- compatible mobile smartphone app that facilitates communication between doctors and patients.
The system was 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 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.”
