Abbott has secured approval from the US Food and Drug Administration (FDA) for its Amplatzer Amulet left atrial appendage (LAA) occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke.
The Amulet device facilitates immediate closure of the LAA, an area where blood clots can form in people suffering from AFib. It will help minimise the risk of stroke and immediately avoid the requirement for blood-thinning medication.
Abbott stated that the only minimally invasive option for LAA occlusion for US physicians and their patients before this approval was a solution with a single component to seal the LAA, which needs blood-thinning drugs to heal and additional patient monitoring to ensure closure.
In contrast, the Amulet uses dual-seal technology for the completion and immediate sealing of the LAA.
The recipients of Amulet have the flexibility to avoid the use of blood-thinning medication following the procedure.
Abbott’s Amulet device also holds the potential to treat a range of anatomies and consists of wide range of occluder sizes on the market.
The FDA approval is based on data from the Amulet IDE trial, which is a large-scale randomised head-to-head study that compared Amulet with an alternative minimally invasive LAA occlusion device.
Abbott structural heart business senior vice president Michael Dale said: “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.
“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.”
Abbott already secured approval for Amplatzer Amulet LAA occluder for use in over 80 countries, including in Europe, Canada and Australia. The device first secured CE mark approval in 2013.
In May this year, Abbott launched a new trial to improve treatment options for patients suffering from both AFib and heart failure.
