Abbott Laboratories’ Amplatzer Amulet left atrial appendage (LAA) occlusion device has been shown at one year to reduce stroke by 57% as compared to the predicted stroke risk. The data also showed it was able to make this reduction without the need for lifetime blood thinners.
The Abbott Park IL-based company released the data at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions in Paris, and simultaneously published in EuroIntervention. More than 1,078 patients suffering from atrial fibrillation (Afib) were in the study with one-year-follow up.
“The Amulet is a device that’s intended to prevent thrombus from escaping from the LAA which is a little pocket coming off the left atrium,” Barathi Sethuraman Divisional Vice President, Global Clinical Affairs, Abbott’s Structural Heart business, told MD+DI. “The atrial fibrillation thrombus can form in the pocket and escape into the brain and cause a stroke.”
The Abbott device works by blocking the LAA at its opening into the left upper chamber of the heart and has CE mark.
Currently, patients with Afib at risk of stroke are often prescribed blood-thinning medication to reduce risk for formation of blood clots, but this treatment approach requires a lifetime of taking medication and comes with risk of major bleeding. By closing the LAA with the Amplatzer Amulet occluder, physicians can "seal off" the LAA to reduce the risk of stroke.
Results show adequate sealing of the LAA was achieved in 99.3% of patients with residual flow less than 3mm at the end of the procedure, and in 98.4% of follow-up studies between one and three months post-implant, as assessed by the echocardiolgraphic core laboratory.
Key one-year clinical events adjudicated by the independent Clinical Events Committee included: Ischemic stroke rate of 2.9% per year (29 events in 27 patients) versus a predicted rate of 6.7 percent; and, device-related thrombus rate of 1.7 percent (18 events in 17 patients). In patient population at high risk for stroke – and major bleeding the need for blood-thinning medication was reduced.
"Managing atrial fibrillation in patients who are at high risk of bleeding with blood thinning medicines is complex, and physicians must carefully weigh a patient's risk for life-threatening bleeds versus stroke," said Ulf Landmesser, M.D., presenter of the latest data and director, Department of Cardiology, Charité Universitätsmedizin in Berlin, Germany, said in a release. "These real-world prospective data provide important information on the clinical use and safety of left atrial appendage occlusion with the Amplatzer Amulet device, and demonstrate excellent occlusion of the left atrial appendage over time."
If Abbott’s Amplatzer Amulet gains FDA approval it could find some tough competition from Boston Scientific’s Watchman LAA Closure device, which has had a significant head start in the U.S. market.
The Marlborough, MA-based company received FDA approval in 2015. Boston Scientific picked up Watchman when it acquired Atritech for $100 million plus milestones of up to $275 million. Abbott gained access to the Amplatzer when it acquired St. Jude Medical for $25 billion in a deal that closed in 2017.