FDA approves new heart rhythm devices featuring Bluetooth connectivity and continuous remote monitoring

Abbott’s Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices are given approval.

two heart rythms - one over red is arrythmic, the other on blue is normal

Abbott has announced that the US Food and Drug Administration (FDA) has approved its next-generation Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices.

According to the enterprise, the device brings new benefits, including a patient-preferred design without compromising battery longevity and Magnetic Resonance Imagery (MRI) compatibility. The devices also offer Bluetooth technology and a new patient smartphone app for improved remote monitoring.

An estimated 6.1 million people in the US battle cardiac arrhythmias 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.

three Abbott Gallant devices

“We are focused on developing and delivering life-changing technologies that impact patient care in a meaningful way,” said Randel Woodgrift, senior vice president, Cardiac Rhythm Management, Abbott. “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.”

The new devices pair with the company’s myMerlinPulse™ smartphone app, compatible with iOS and Android™, that provides people with access to data on device performance and transmission history. The app also allows physicians to 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 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,” said Raffaele Corbisiero, MD, FACC, director of electrophysiology and pacing at Deborah Heart and Lung Center, US. “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.”

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

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