Abbott Receives FDA Approval for Gallant Heart Rhythm Implants Featuring Continuous Remote Monitoring

Abbott FDA Approval Gallant Heart Rhythm Implants
Entrance to Abbott Ireland at Cootehill (Image credit: Eric Jones, via geograph)

Abbott won FDA approval for its next-generation Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. Cleared in Europe earlier this year, the implants feature Bluetooth connectivity, allowing data to stream to a physician for closer observation and monitoring.

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The devices bring new benefits to patients with heart rhythm disorders, including a patient-preferred design without compromising battery longevity and MRI compatibility.

In a healthy heart, the rate and rhythm of the heartbeat are controlled by an electrical system. A series of coordinated electrical signals start in a part of the heart, called the Sinus Node. The electrical impulse then spreads across the heart and tells it when and where to contract or squeeze. The synchronized heartbeat continuously circulates blood from the lungs through the heart and out to the rest of the body to deliver oxygen.

In people with Atrial Fibrillation (AFib), the electrical signals are abnormal and largely chaotic. It causes the heart’s chamber to beat irregularly and often rapidly. If you’ve been diagnosed with AFib, you’re not alone. AFib is the most common type of irregular heartbeat.

An estimated 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, says a press release.

“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.”

Drawing of a human heart
In people with Atrial Fibrillation (AFib), the electrical signals are abnormal, and largely chaotic. It causes the heart’s chamber to beat irregularly and often rapidly. (Image: Alliance for Aging Research)

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 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, M.D., FACC, director of electrophysiology and pacing at Deborah Heart and Lung Center, Browns Mills, N.J. “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.”

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Abbott’s portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

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