FDA clears Abbott’s Gallant devices for cardiac arrhythmia
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FDA clears Abbott’s Gallant devices for cardiac arrhythmia

07 Jul 2020

Abbott has received the US Food and Drug Administration (FDA) approval for its Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices.

FDA clears Abbott’s Gallant devices for cardiac arrhythmia
Abbott secured CE Mark for Gallant ICD and CRT-D devices in Europe in February. Credit: Abbott.

Abbott has received the US Food and Drug Administration (FDA) approval for its Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices.

The new Gallant system offers Bluetooth capability and pairs with the company’s myMerlinPulse, an iOS and Android-compatible smartphone app.

The features help to optimise patient engagement and streamline communications between doctors and their patients, the company noted.

myMerlinPulse app also helps in earlier intervention by allowing continuous remote monitoring. It reduces clinical burden by enabling physicians to identify asymptomatic episodes and patient-triggered transmissions.

Additionally, the app helps patients to take an active role in their healthcare by providing them with access to data, device performance and transmission history.

The new defibrillators also offer battery longevity and magnetic resonance imaging (MRI) compatibility to patients with heart rhythm disorders.

Approximately 6.1 million people in the US suffer from cardiac arrhythmias or abnormal heart rhythms.

ICDs are used to reduce the risks of life-threatening arrhythmias, while CRT-Ds can be used to restore the heart’s natural pattern of beating in patients with heart failure.

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

“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.”

Earlier in February, Abbott obtained CE Mark for Gallant ICD and CRT-D devices in Europe.

Last month, the company reported a positive outcome for its optical coherence tomography (OCT) imaging techniques based on the data generated by the LightLab Initiative.