Global Amplatzer Amulet IDE Trial Evaluates St. Jude Medical's Next-Generation LAA Occluder

September 6, 2016—St. Jude Medical, Inc. announced last week the start of an investigational device exemption (IDE) trial that will evaluate the safety and effectiveness of the company’s Amplatzer Amulet left atrial appendage (LAA) occluder in patients diagnosed with nonvalvular atrial fibrillation. Jim Stone, MD, performed the first implantation in the study at North Mississippi Medical Center in Tupelo, Mississippi.

According to St. Jude Medical, the Amplatzer Amulet IDE trial is a randomized trial that will enroll patients at up to 100 sites in the United States and an additional 50 sites internationally. Data collected across all trial sites will be used to support US Food and Drug Administration (FDA) approval of the Amplatzer Amulet occluder device. Patients enrolled in the trial will be randomly assigned to receive either the Amulet device or a currently FDA-approved LAA closure device in the control arm of the study.

The Amplatzer Amulet, which received CE Mark approval and is available in Europe, is the second-generation St. Jude Medical LAA occlusion device. It is built with a longer lobe and waist than the previous version and designed to allow for easier and more stable placement, which could result in shorter procedure times for patients. The Amplatzer Amulet device is also offered in eight sizes to accommodate varying anatomies, advised St. Jude Medical.

The trial’s Principal Investigator, Dhanunjaya Lakkireddy, MD, commented in the company’s announcement, “There’s a real need within the United States medical community for a LAA occluder that addresses a wider range of complex patient anatomies. The Amulet device has been used successfully in Europe, and I see this IDE trial as the right step toward providing patients with atrial fibrillation the optimal level of care to further reduce the risk of stroke.” Dr. Lakkireddy is Professor of Medicine and the Director of the Center for Excellence in Atrial Fibrillation and Complex Arrhythmias at the University of Kansas in Kansas City, Kansas.