FDA approves bluetooth enabled implantable defibrillator for remote monitoring

The U.S. Food and Drug Administration (FDA) has approved a next-generation bluutooth enabled Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices.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.

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

The Gallant system that received food and drug administration (FDA) approval had received CE Mark for use across Europe earlier this year.

Heart conditions are common in the US. In fact, atrial fibrillation impacts between 2.7 million and 6.1 million people in the United States, according to the CDC. The company Abbott is pitching this product as another way for doctors to monitor their patients' heart conditions remotely and this food and drug administration (FDA) approval is a welcome step.

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.

"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 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."

For important safety information, please visit abbott.com.