Abbott’s Amplatzer Amulet gains US FDA approval

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Amplatzer Amulet
Amplatzer Amulet

Abbott has announced that the US Food and Drug Administration (FDA)  has approved the company’s Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AF) who are at risk of ischaemic stroke. The device offers immediate closure of the left atrial appendage (LAA)—an area where blood clots can form in people suffering from AF—reducing their risk of stroke and immediately eliminating the need for blood-thinning medication.

The LAA is a small pouch connected to the upper left chamber of the heart. For patients with AF who are unable to take blood-thinning medication long term, physicians may opt for occlusion (or closure) of the LAA through a minimally invasive procedure using devices like Abbott’s Amulet to seal off the LAA entirely and reduce the risk of stroke.

“As the world’s population continues to age, we’re seeing a surge in atrial fibrillation cases, and with that comes increased risk of stroke,” said Dhanunjaya Lakkireddy, Kansas City Heart Rhythm Institute at HCA Midwest Health, Kansas City, USA who served as principal investigator for the study that led to FDA approval. “The approval of Abbott’s Amulet device provides physicians with a treatment option that reduces the risk of stroke and eliminates the need for blood-thinning medication immediately after the procedure, which is incredibly valuable given the bleeding risks associated with these medicines.”

Abbott’s Amulet uses dual-seal technology to completely and immediately seal the LAA. Amulet recipients do not need to use blood-thinning medication following the procedure. Additionally, the device can treat a broad range of anatomies and has the widest range of occluder sizes on the market, Abbott says. It is also recapturable and repositionable to ensure optimal placement.

“Amulet’s unique dual-seal approach has made it the number one LAA closure product in Europe, so today’s device approval by the FDA is an important milestone in allowing us to bring this treatment option to American physicians and patients,” said Michael Dale, senior vice president of Abbott’s structural heart business. “Consistent with our mission purpose, our minimally invasive Amulet procedure for reducing stroke risk in patients with atrial fibrillation will help people live better lives through better health.”


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