February 09, 2017
AUSTIN, TEXAS—On December 13, 2016, the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center became the first facility in Texas to implant the new AMPLATZER™ Amulet™ Left Atrial Appendage Occluder to seal off the left atrial appendage (LAA)—a small appendage connected to the left atrium—in patients diagnosed with non-valvular Atrial Fibrillation (A Fib). The AMPLATZER™ Amulet™ Left Atrial Appendage Occluder is currently being evaluated in the AMPLATZER Amulet U.S. IDE (investigational device exemption) Clinical Trial.
Rodney Horton, M.D., a cardiac electrophysiologist at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, implanted the AMPLATZER Amulet occluder to reduce the risk of stroke in a patient suffering from non-valvular A Fib.
“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,” Dr. Horton said. “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 occluder works by blocking the LAA at its opening, which minimizes the opportunity for blood clots to form in the LAA and migrate into the bloodstream, potentially causing a stroke. The AMPLATZER Amulet 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.
In some patients with A Fib, the LAA does not contract effectively, causing blood clots. The clots can then be released into the heart and enter the bloodstream, where they can travel to the brain and cause a stroke. Currently, patients with A Fib who are at risk of stroke are often prescribed blood-thinning medication, but this treatment approach comes with a lifetime of medical management and the risk of major bleeding. By closing the LAA with the AMPLATZER Amulet occluder, physicians can “seal off” the LAA and potentially reduce the risk of stroke.
The AMPLATZER Amulet IDE trial is a randomized trial, which will enroll patients at up to 100 sites in the United States—including TCAI—and an additional 50 sites internationally. Patients enrolled in the AMPATZER Amulet IDE trial will be randomly assigned to receive either the Amulet device or an FDA-approved LAA closure device in the control arm of the study. Data collected across all trial sites will be used to support FDA approval of the AMPLATZER Amulet occluder.