Pivotal trial pits St. Jude Medical’s Amplatzer Amulet anti-stroke device against Boston Scientific’s Watchman

St. Jude Medical (NYSE:STJ) said today that it launched a U.S. pivotal trial for its Amplatzer Amulet cardiac implant, which is designed to reduce the risk of stroke in patients with atrial fibrillation.

The Amplatzer Amulet device is designed to occlude the left atrial appendage to prevent the formation of blood clots that could lead to a stroke. The FDA approved a similar device made by Boston Scientific (NYSE:BSX), the Watchman implant, in March 2015; St. Jude’s 1,600-patient IDE trial will compare the Amplatzer Amulet to the Watchman in patients with non-ventricular arrhythmias.

The primary safety endpoint is a composite of procedure-related complications, all-cause death and major bleeding at 12 months; the main efficacy outcome is a composite of ischemic stroke or systemic embolism at 18 months, according to ClinicalTrials.gov.

The 1st implantation in the investigational device exemption trial was performed at the North Mississippi Medical Center in Tupelo, the company said. Little Canada, Minn.-based St. Jude won CE Mark approval in the European Union for the Amplatzer Amulet in January 2013.

“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,” chief medical officer Dr. Mark Carlson said in prepared remarks. “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.”

“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,” added Dr. Dhanunjaya Lakkireddy of 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.”

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