Abbott secured CE mark approval for the Amplatzer Amulet device in 2013
Abbott’s trial will assess the efficacy of Amplatzer Amulet device to treat people with atrial fibrillation (Credit: Abbott)
Healthcare company Abbott has secured approval from the US Food and Drug Administration (FDA) to begin a new trial for the assessment of its Amplatzer Amulet left atrial appendage (LAA) occluder to treat people with atrial fibrillation (AF).
AF is a condition in which the normal rhythm of the heart’s upper chambers will be discomposed and turn into abnormal, leading to stroke.
CATALYST trial will compare the effectiveness of the Abbott Amplatzer Amulet to NOAC drugs
CATALYST is claimed to be the first-ever clinical study designed to compare the effectiveness of an LAA closure device to a newer class of blood thinners called non-vitamin K antagonist oral anticoagulant (NOAC) drugs.
CATALYST trial principal investigator Dr Vivek Reddy said: “A device that can address a significant structural issue of the heart via a minimally invasive procedure would be a significant step forward for patients with atrial fibrillation eligible for long-term NOAC therapy.”
The Amplatzer Amulet device, which enables physicians to permanently seal off the LAA, will be delivered to the heart via a small minimally invasive incision in the leg.
The global and multicentre trial will compare the efficacy of the Amplatzer Amulet to NOACs as an alternative treatment option in an expanded population of AF patients.
Abbott will randomise up to 2,650 subjects at 150 sites across the world in the trial to evaluate whether sealing off the LAA with the Amulet device will serve as a viable alternative to a lifetime of these newer blood thinners.
In 2013, Abbott secured CE mark approval for the Amplatzer Amulet device and is marketed in Europe and other countries that accept CE mark. At present, the Amplatzer Amulet device is used for the investigational purpose only in the US.
Abbott’s structural heart business chief medical officer Dr Neil Moat said: “The CATALYST trial has the potential to provide data for the Amplatzer Amulet LAA Occluder that could change clinical practice by eliminating a lifetime need for blood thinners – reinforcing our mission of helping people live better lives through better health.”
Recently, Abbott secured CE mark approval for its Tendyne Transcatheter Mitral Valve Implantation (TMVI) system for use in the European Union.