FDA Approves Implantable Heart Rhythm Monitoring Devices

The US Food and Drug Administration (FDA) has approved Abbott’s Gallant implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator devices.

The technologies help patients with heart rhythm disorders and feature Bluetooth and a new patient smartphone app to improve remote monitoring and increase patient-physician engagement and streamlined communication.

“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,” Raffaele Corbisiero, MD, FACC, director of electrophysiology and pacing at Deborah Heart and Lung Center in New Jersey, said in a statement.

The Gallant system pairs with Abbott’s secure myMerlinPulse, which is an iOS- and Android-compatible smartphone app. Patients who use the app can access data, device performance, and transmission history, helping them be more active in their healthcare. Physicians can use the app to continuously monitor their patients remotely, which could lead to the identification of asymptomatic episodes and patient-triggered transmissions.

An estimated 6.1 million people in the US have cardiac arrhythmias. Implantable cardioverter defibrillators can help reduce the risk of life-threatening arrhythmias. If patients have heart failure or are in a situation when the heart chambers beat out of sync, cardiac resynchronization therapy defibrillator devices can help restore the heart’s natural beating pattern.

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