St. Jude Medical’s Amplatzer Amulet meets safety, efficacy marks in observational study
The nearly 1,100-patient trial had a technical success rate of 98.8%. Major adverse events within 7 days included ischemic stroke (0.3%), pericardial effusion requiring intervention (0.5%), embolization (0.1%), and bleeding (0.9%). There were 3 deaths (0.2%) within seven days of attempted implant, 2 of which were adjudicated as procedure- or device-related, and 1 as unrelated to the device. At 1-3 month follow-up, the majority of patients were on antiplatelet therapy only and transesophageal echocardiography showed a closure rate of 99%.
“These results indicate that the Amplatzer Amulet is safe and associated with low rates of peri-procedural and early adverse events, as well as demonstrating high closure rates,” Dr. David Hildick-Smith, of Brighton, England’s Sussex University Hospitals, said in prepared remarks. “In addition, antiplatelet therapy appears to be an effective treatment strategy post-implantation in the short term. Additional long-term data is necessary to confirm these promising early findings.”
“Initial data from this large-scale observational study continue to affirm the AMPLATZER Amulet LAA Occluder as an important treatment option to reduce the risk of stroke in patients with non-valvular AF,” added St. Jude vice president Dr. Srijoy Mahapatra. “The Amplatzer Amulet occluder has favorable closure rates when compared to other device reports in a similar patient group.”