|The Lariat Suture Delivery Device--Courtesy of SentreHeart|
The U.S. Food and Drug Administration issued an alert that patient deaths and other serious adverse events have occurred due to the off-label use of the Lariat Suture Delivery Device marketed by startup SentreHeart. It's approved to deliver sutures for soft tissue closure, but surgeons have been using it to close the left atrial appendage in order to prevent stroke in patients with irregular heart rhythm.
In May, researchers first reported the issue in a paper published in JAMA Internal Medicine. The company quickly said that it planned to start a trial in the atrial fibrillation indication.
Then in June, SentreHeart said it had gained an FDA nod to start a clinical trial of Lariat to close the left atrial appendage (LAA) as an adjunctive treatment to ablation in patients with persistent or long-standing persistent atrial fibrillation. 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.
Dubbed the AMAZE trial, the two-stage afib clinical test of Lariat is slated to enroll up to 600 patients, with as many as 175 million at 15 centers during the first stage alone. The procedure will be performed on atrial fibrillation patients who are candidates for pulmonary vein isolation (PVI) catheter ablation.
The trial is intended to compare the use of PVI ablation plus Lariat to the use of PVI alone.
"The left atrial appendage has been accurately termed our most lethal human attachment," Dr. James Cox, a surgeon who developed the first ablation treatment for atrial fibrillation, said in a statement about the AMAZE trial. "The Lariat is the only percutaneous device that can provide the electromechanical isolation of the myocardium of the LAA by devascularization and, when combined with PVI ablation, would seem to be the one most likely to improve catheter ablation outcomes for afib."
The Lariat isn't the only controversial device treatment in the indication. In March, Boston Scientific ($BSX) secured approval for its Watchman device to prevent LAA blood clots from entering the bloodstream and potentially causing a stroke. The approval only came after years of FDA panels and subsequent rejections. In April, 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.
- here is the FDA warning