St. Jude Medical ($STJ) launched a pivotal trial to look at the effectiveness of its Amplatzer Amulet device when used to close a left atrial appendage (LAA) in order to prevent stroke in patients with irregular heart rhythm.
The trial will enroll patients at up to 100 sites in the U.S. and will be conducted at an additional 50 sites globally, the company said. Information gathered during the trial will be used to support FDA approval. The device is already approved and available in Europe.
Use of such devices to treat LAA triggered controversy when the FDA in July 2015 issued an alert that patient deaths and other serious adverse events occurred due to the off-label use of the Lariat Suture Delivery Device marketed by startup SentreHeart. The alert came a month after the issue surfaced in a paper published in JAMA Internal Medicine.
The treatment of atrial fibrillation is intended to reduce the incidence of stroke caused by a blood clot in the LAA detaching and traveling through the bloodstream to the brain.
“There’s a real need within the United States medical community for a left atrial appendage occluder that addresses a wider range of complex patient anatomies,” Dr. Dhanunjaya Lakkireddy, director of the Center for Excellence in Atrial Fibrillation and Complex Arrhythmias at the University of Kansas, said in a statement. “The Amulet device has been used successfully in Europe, and I see this IDE trial as the right step toward providing patients with atrial fibrillation the optimal level of care to further reduce the risk of stroke.”
The first implant of the study took place at North Mississippi Medical Center in Tupelo, Mississippi, the company said.
St. Jude and SentreHeart aren’t alone in the LAA market. A little over a year ago Boston Scientific ($BSX) secured FDA approval for its Watchman device to prevent LAA blood clots from entering the bloodstream and potentially causing a stroke. Still, the regulatory nod came after years of FDA panels and subsequent rejections.
The month after the Watchman approval, Maquet had a Class I recall of all units of its TigerPaw System II left atrial appendage closure device after reports of tissue tearing and bleeding.
About 15 million strokes occur globally each year, according to World Health Organization stats cited by St. Jude. An estimated 87% of all strokes occur when clots block the blood vessels to the brain, and stroke is the third leading cause of death and the leading cause of long-term disability.