News & Trends - MedTech & Diagnostics
Abbott’s atrial fibrillation device shows superiority against Boston Scientific technology

MedTech News: Patients with non-valvular atrial fibrillation (NVAF) are at increased risk for ischaemic stroke. Oral anticoagulation is recommended to reduce stroke risk, but percutaneous left atrial appendage (LAA) occlusion may be considered in patients with contraindications to long-term anticoagulation due to risk of bleeding, according to the European Society of Cardiology (ESC) guidelines.
Abbott’s Amplatzer Amulet Left Atrial Appendage Occluder has shown superior LAA closure and noninferior safety and effectiveness for stroke prevention in patients with NVAF compared to Boston Scientific’s Watchman device. That is the finding of late breaking research presented at this week’s ESC Congress 2021.
The Amulet IDE trial was the first multicentre randomised trial comparing the Amulet LAA occluder head-to-head with the Watchman device. Both are percutaneous transcatheter devices intended to prevent the migration of blood clots from the LAA and reduce the incidence of thromboembolic events in patients with NVAF.
While both devices close off the LAA, the mechanism differs. The Amulet LAA occluder dual-seals the LAA by two mechanisms using the device’s lobe and disc: 1) filling the neck of the LAA with the lobe and 2) covering the LAA ostium with the disc. In contrast, the Watchman device only fills the body of the LAA.
Principal investigator Professor Dhanunjaya Lakkireddy of the Kansas City Heart Rhythm Institute and Research Foundation, US said “The Amulet LAA occluder was superior with respect to LAA closure and noninferior with respect to safety and effectiveness for stroke prevention in patients with NVAF compared to the Watchman device. The dual seal design of the Amulet LAA occluder helps to overcome the limitations of a single seal device, including but not limited to short LAA length, proximal lobes near the ostium, and very large ostia. In addition, immediate closure of the LAA with the Amulet disc allows some patients to be treated without the need for anticoagulation therapy after the procedure.”
Device based LAA closure rates were higher and demonstrated superiority of the Amulet LAA occluder compared with the Watchman device (98.9% versus 96.8%; p<0.001 for noninferiority; p=0.003 for superiority). A detailed analysis of residual jet at 45 days revealed no flow around the device in 63% of Amulet patients compared to 46% of Watchman patients.
The Amulet LAA occluder was noninferior to the Watchman device for the primary safety endpoint (14.5% versus 14.7%; p<0.001 for noninferiority) and the primary effectiveness endpoint (2.8% versus 2.8%; p<0.001 for noninferiority).
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