Abbott receives FDA approval for new heart rhythm devices featuring Bluetooth connectivity and continuous remote monitoring
implantable cardioverter defibrillator family of devices offers Bluetooth® capability for a more meaningful connection between patients and their doctors
Gallant ICD and CRT-D devices feature a patient-preferred design without compromising on battery longevity and compatibility with magnetic resonance imaging (MRI)
ABBOTT PARK, IL (STL.News) Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s next-generation Gallant
It is estimated that as many as 6.1 million people in the United States battle cardiac arrhythmias, or abnormal heart rhythms,1 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.
“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
“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.”
The Gallant system received CE Mark for use across Europe earlier this year.