News | Left Atrial Appendage (LAA) Occluders | September 02, 2016

St. Jude Medical Launches Amplatzer Amulet LAA Occluder Trial

IDE trial will expand access to the left atrial appendage occluder device to patients in the United States who are in need of LAA closure to reduce their risk of stroke

St. Jude Medical, Amplatzer Amulet LAA occluder, left atrial appendage, IDE trial

September 2, 2016 — St. Jude Medical Inc. announced the start of the St. Jude Medical Amplatzer Amulet IDE trial of the company’s Amplatzer Amulet Left Atrial Appendage (LAA) Occluder. The trial will evaluate the safety and effectiveness of the device, used to close the LAA in patients diagnosed with non-valvular atrial fibrillation (AF). The first implant of the study took place at North Mississippi Medical Center in Tupelo, Miss., by Jim Stone, M.D.

In most people, the LAA — a small appendage connected to the left atrium — does not increase the risk of adverse health effects, but in some patients with atrial fibrillation, the LAA does not contract effectively and it can become a source of blood clots. These 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 AF 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 device 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. The Amplatzer Amulet occluder, the second-generation St. Jude Medical LAA occlusion device, 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 device is also offered in eight sizes to accommodate varying anatomies.

“There’s a real need within the United States medical community for a left atrial appendage occluder that addresses a wider range of complex patient anatomies,” said Dhanunjaya Lakkireddy, M.D., professor of medicine and the director of the Center for Excellence in Atrial Fibrillation and Complex Arrhythmias at the University of Kansas. “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.”

The AMPLATZER Amulet IDE trial is a randomized trial, which will enroll patients at up to 100 sites in the United States and an additional 50 sites internationally. Patients enrolled in the AMPLATZER Amulet IDE trial will be randomly assigned to receive either the St. Jude Medical Amulet device or a U.S. Food and Drug Administration (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.

The Amplatzer Amulet Left Atrial Appendage Occluder is CE Mark approved and available in Europe.

For more information: www.sjm.com

Related Content

Edwards Lifesciences Centera self expanding transcatheter (TAVR) valve
News | Heart Valve Technology| May 24, 2017
May 24, 2017 — Late-breaking data presented at EuroPCR 2017 demonstrating excellent clinical outcomes for...
3-D Echo Image Analysis With Philips' HeartModel A.I. is Accurate and Reproducible
News | Cardiovascular Ultrasound| May 24, 2017
May 24, 2017 — Philips recently announced the results from a global study indicating that automated...
Heart Failure Mortality Inversely Related to Wealth of Country
News | Heart Failure| May 24, 2017
Death in patients with heart failure is inversely related to the wealth of the country they live in, according to late...
Shockwave Medical Announces CE Mark for Coronary Lithoplasty System and Activities at EuroPCR 2017
News | Cath Lab| May 23, 2017
Shockwave Medical announced last week CE Mark for the company’s Coronary Lithoplasty System for the treatment of...
New Paper Highlights Success of Advanced Treatments in Complex Aortic Aneurysm Repair
News | Endovascular Aortic Repair| May 23, 2017
Significant success has been achieved in treating complex proximal aneurysms using a combination of fenestrated and...
Risk of Heart Transplant Rejection Reduced by Desensitizing Patient Antibodies
News | Cardiovascular Surgery| May 23, 2017
The risk of heart transplant rejection can be reduced by desensitizing patient antibodies, according to research...
News | Heart Failure| May 22, 2017
Serelaxin failed to meet the primary endpoints of the phase 3 RELAX-AHF-2 trial, according to late-breaking results...
Consumers Warned About Accuracy of Heart Rate Apps in New Study
News | Mobile Devices| May 22, 2017
May 22, 2017 — Consumers are being warned about the accuracy of heart rate apps after a study found huge variability
Abbott recalls its NC Balloon catheters
News | Balloon Catheter| May 22, 2017
May 22, 2017 — Abbott Vascular has initiated a voluntary recall of specific lots of three catheters due to 19 reports
Overlay Init