Abbott won a CE mark approval for the Amulet 360 left atrial appendage occluder, aimed at reducing stroke risk in patients with non-valvular atrial fibrillation. The clearance gives Abbott another product in the LAA occlusion market where competition is dominated by Boston Scientific’s Watchman franchise. Abbott said the device is designed for growth in the roughly $2 billion global LAAO market, reinforcing how medtech expansions can change referral patterns in structural heart disease. For healthcare stakeholders, the decision highlights the continuing role of regulatory marks outside the US as key commercial inflection points in cardiovascular device adoption.
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