Study of Amplatzer Amulet left atrial appendage (LAA) occluder shows success rate in patients diagnosed with non-valvular atrial fibrillation (AF)- St Jude Medical

St. Jude Medical has presented favorable results from the largest observational study to date of the company�s Amplatzer Amulet left atrial appendage (LAA) occluder in patients diagnosed with non-valvular atrial fibrillation (AF). The prospective, multicenter, international AMPLATZER Amulet Observational Study of LAA occlusion (closure) enrolled 1,073 patients at 64 centers across 18 countries.

Initial results from the study showed a 98.8 percent implant success rate adding to the clinical evidence that the AMPLATZER Amulet LAA Occluder is a safe alternative for prevention of stroke in patients with non-valvular atrial fibrillation (AF). Closure rate was 99 percent at one to three month follow-up visit (n=364). Closure was defined as absence of flow or flow of below 3 mm jet into the LAA.

All echocardiography results were adjudicated by an independent core lab. Acute device/procedure related major adverse events within seven days post procedure occurred in 2.7 percent (29) of 1,073 patients. The data were presented in a Late Breaking Clinical Trial session at the Transcatheter Cardiovascular Therapeutics (TCT) Conference.