Abbott’s Gallant Heart Rhythm Implants FDA Approved


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

The devices connect to the myMerlinPulse smartphone app, available for Android and iOS smartphones and tablets, and can share details about adverse events, how the device is performing, and a log of all the transmissions. Such close scrutiny can help to diagnose difficult to spot events, such as arrhythmias, and review those events that patients themselves can tag for their cardiologists to take a closer look at.

The Gallants are MRI compatible, allowing patients to receive scans as long as certain precautions are taken.

“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.”

Flashback: Abbott’s Gallant Cardiac Implants Cleared in Europe

Via: Abbott

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