Abbott has received approval from the US Food and Drug Administration (FDA) to commence a new trial for the evaluation of its Amplatzer Amulet left atrial appendage (LAA) occluder to treat people with atrial fibrillation (AF).
AF is as a condition where the normal rhythm of the heart’s upper chambers gets interrupted, which can lead to stroke.
Abbott claims that the CATALYST is the first-ever clinical study developed to compare the efficiency of an LAA closure device to a newer class of blood thinners called non-vitamin K antagonist oral anticoagulant (NOAC) drugs.
Amplatzer Amulet device helps doctors to permanently seal off LAA, delivered to the heart via a minimally invasive incision in the leg.
The global and multicentre trial will compare the efficiency of the Amplatzer Amulet to NOACs as an alternative treatment option for the increasing AF patients.
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.”
Abbott will randomise up to 2,650 subjects at 150 sites worldwide in the trial to evaluate whether sealing off LAA with the Amulet device will provide a feasible alternative.
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.”
In 2013, Abbott secured CE mark approval for the Amplatzer Amulet device. It is commercially available in Europe and other countries where they accept the CE mark.
Currently, the device is used only in the US for investigational purpose.
Last month, Abbott secured approval from the US Food and Drug Administration (FDA) for its Infinity Deep Brain Stimulation (DBS) system to treat Parkinson’s disease.