The Texas Cardiac Arrhythmia Institute at St David’s Medical Center, Austin, USA became the first facility in the US state of Texas to implant the new Amplatzer Amulet left atrial appendage (LAA) occluder from St Jude Medical to seal off the left atrial appendage in patients diagnosed with non-valvular atrial fibrillation (AF). The device is currently being evaluated in the AMPLATZER Amulet US Investigational Device Exemption (IDE) clinical trial.
Rodney Horton, a cardiac electrophysiologist at the Texas Cardiac Arrhythmia Institute at St David’s Medical Center, implanted the occluder to reduce the risk of stroke in a patient suffering from non-valvular AF.
“What makes this device unique is that it closes the LAA without requiring a very deep structure, allowing us to close LAAs that could otherwise not be closed,” Horton says. “It is also made from a material that allows for the use of Plavix and aspirin, rather than full-strength blood thinners.”
The Amplatzer Amulet is designed to work by blocking the LAA at its opening, which minimises the opportunity for blood clots to form in the LAA and migrate into the bloodstream. The occluder is built with a longer lobe and waist than the previous version, and it is designed to allow for easier and more stable placement, which could result in shorter procedure times for patients. It comes in eight sizes to accommodate varying anatomies to address a wider range of complex patient anatomies than other LAA occluders.
The AMPLATZER Amulet IDE trial is a randomised trial, which will enrol patients at up to 100 sites in the USA, and an additional 50 sites internationally. Patients enrolled in the trial will be randomly assigned to receive either the Amulet device or a Food and Drug Administration-approved LAA closure device in the control arm of the study.