Three year outcomes from Amulet IDE study of Amplatzer Amulet LAA Occluder presented at TCT meeting

Data include findings that reinforce the value of MitraClip, the world's first and leading transcatheter edge-to-edge repair (TEER) device, to treat leaky valves in people with mitral regurgitation (MR). ( see separate entry) The new data around Abbott's structural heart therapies were presented at the 34th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation in Boston (September 16-19, 2022).

Three-Year Outcomes from the Amulet IDE Study: The Amplatzer Amulet LAA Occluder with dual-seal technology (consisting of a lobe or piece to fill the cavity of the LAA and a disc to close off the opening into the LAA) is the first and only minimally invasive treatment option to offer immediate and complete dual-sealing closure of the LAA, reducing the risk of stroke and eliminating the need for blood-thinning medication.

The prospective, international, multi-center Amulet IDE trial is the largest randomized LAA occlusion study to date consisting of more than 1,800 patients, and three-year outcomes demonstrate the safety and effectiveness of Amulet, with data showing: Device-related factors (device-related thrombosis or peri-device leak) more frequently preceded strokes in patients with Boston Scientific's Watchman‡ than those with AmuletBoth cardiovascular and all-cause death trended higher in the Watchman device than the Amulet device.

PREDICT-LAA Trial (Amulet): Data were also presented from the PREDICT-LAA prospective, multi-center, randomized controlled trial that studied if the use of cardiac computed tomography-based computational models (high-resolution scans of patients' hearts generated by FEops HEARTguide) help in the planning of Amplatzer Amulet procedures. Key findings at three months include: Improved procedural efficiency and safety outcomes with the Amplatzer Amulet LAA Occluder were achieved when planned with HEARTguide.