St. Jude Medical (STJ) Commences AMPLATZER Amulet IDE Trial

September 1, 2016 9:02 AM EDT

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St. Jude Medical, Inc. (NYSE: STJ) announced the start of the St. Jude Medical AMPLATZER Amulet IDE trial, which will evaluate the safety and effectiveness of the company’s AMPLATZER™ Amulet™ Left Atrial Appendage Occluder used to close the left atrial appendage (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, Mississippi by Dr. Jim Stone.

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 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. 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 AMPLATZER Amulet 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 Dr. Dhanunjaya Lakkireddy, 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 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.

“The AMPLATZER Amulet device, which is the current market leader among left atrial appendage occluders in Europe, was developed to provide physicians additional treatment options to improve patient care,” said Mark Carlson, M.D., chief medical officer and vice president of medical affairs at St. Jude Medical. “Enrollment in the AMPLATZER Amulet IDE trial will take us one step closer to bringing this important technology to patients in the United States who are at an increased risk of stroke due to atrial fibrillation.”

According to the World Health Organization (WHO), an estimated 15 million strokes occur worldwide each year. In 2010, stroke cost the United States an estimated $53.9 billion in health care services, medications and missed days of work. Approximately 87 percent of all strokes are ischemic, which occur when blood clots block the blood vessels to the brain. Stroke is the third leading cause of death and the No. 1 cause of long-term disability. AF is responsible for approximately 20 percent of ischemic strokes and about one-third of AF patients will have a stroke in their lifetime if not treated appropriately.

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

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