ABT · News · 20260827N

Regulatory Approval Milestones

ABBOTT LABORATORIES · 2026-08-27 · Importance 38 · Surprise 60 · In source text

Abbott received CE Mark approval for its next-generation Amulet 360 left atrial appendage occluder in Europe on August 27, 2026. The device is intended for patients with non-valvular atrial fibrillation who face stroke risk and may reduce reliance on blood-thinning medication. Amulet 360 incorporates design updates intended to improve implant conformity and sealing of the left atrial appendage compared with Abbott’s first-generation device. Recent clinical trial data reportedly met safety and effectiveness benchmarks, supporting European commercialization of the product.

Key facts

• Abbott's Amulet 360™ Left Atrial Appendage (LAA) Occluder received CE Mark on Aug. 27, 2026. source
• A headline reported that 'The FDA Just Gave Abbott a Diabetes First.' source
• Amulet 360 is a next-generation device designed to reduce risk of stroke in patients with atrial fibrillation (AFib) not caused by a heart valve issue (non-valvular). source
• Amulet 360 helps seal the left atrial appendage (LAA) of a person's heart, reducing the need for blood-thinning medication. source
• Amulet 360 builds upon Abbott's first-generation LAA device with design updates to enhance how the implant conforms to and seals the LAA. source
• Recent clinical trial data show Amulet 360 met benchmarks for safety and effectiveness. source

Impact estimates