Abbott Amulet 360 Recebe Marca CE na Quarta Aprovação em Eletrofisiologia

Abbott recebeu a Marca CE para seu oclusor de apêndice atrial esquerdo Amulet 360, liberando o dispositivo de prevenção de AVC de próxima geração para venda na Europa e ampliando uma sequência de aprovações em eletrofisiologia que já chegou a quatro em pouco mais de um ano. O anúncio de 27 de agosto de 2026 coloca em movimento o lançamento europeu de uma linha de produtos que a Abbott transferiu para seu segmento de eletrofisiologia no início de 2026, um segmento que gerou $788 milhões em vendas do primeiro trimestre, alta de 16,7 % em relação ao ano anterior.

The clearance covers the Amulet 360 Left Atrial Appendage Occluder, a dual-seal implant designed to close off the small pouch in the heart’s upper left chamber where clots most commonly form in patients with non-valvular atrial fibrillation. For patients who cannot take blood-thinning medication long-term, sealing the appendage offers a mechanical alternative to anticoagulation. The first European cases were completed by Prof. Boris Schmidt at Cardiovascular Clinic Bethanien in Frankfurt, Prof. Ingo Eitel at University Heart Center in Lubeck, and Prof. Jens Erik Nielsen-Kudsk at Aarhus University Hospital in Denmark. Abbott said it will expand availability across European countries in the coming weeks.

Em que se baseia a aprovação

CE Mark for Amulet 360 was supported by the VERITAS Study, a single-arm pivotal trial that enrolled 400 patients across more than 30 hospitals in the U.S., Canada, and Europe. The 45-day results, first presented at the AF Symposium in Boston on Feb. 6, 2026 and published simultaneously in JACC: Clinical Electrophysiology, showed the device was successfully implanted in 99.8% of patients, with 93.9% achieving complete closure of the appendage by 45 days and zero leaks greater than 3 millimeters. On safety, Abbott reported no patient complications such as additional surgery, strokes, or blood clots within the first seven days after implantation.

The trial registry record describes the study under an FDA investigational device exemption, with the device listed as “Amulet 2” and a primary effectiveness endpoint of LAA occlusion at 45 days assessed by an independent core laboratory. The study’s estimated completion date is setembro de 2027, reflecting the longer follow-up that a CE Mark does not require but a U.S. approval application will.

The device itself redesigns the lobe, the component that sits inside the appendage, making it softer and more conformable than the first-generation Amplatzer Amulet to accommodate a wider range of appendage shapes. Smaller anchors secure it in place, and an outer disk provides a second sealing layer. The first-generation device has been used in Europe since 2013 and in the U.S. since 2021.

“With Amulet 360, doctors can help protect more people with AFib from stroke by confidently closing the left atrial appendage,” said Xavier Freixa, M.D., Ph.D., at Hospital Clínic de Barcelona, Spain, and a globally recognized interventional cardiologist. “By helping doctors treat a wider range of anatomies, this next-generation device has the potential to improve outcomes and help more people benefit from stroke prevention across Europe.”

Onde o Amulet 360 se enquadra no negócio de dispositivos da Abbott

The clearance lands in a segment Abbott has been actively reshaping. On Jan. 1, 2026, the company transferred the Amplatzer Amulet device and its accessories from its Structural Heart unit into Electrophysiology, a move disclosed in its first-quarter 2026 results that shifted $46 million of prior-year quarterly sales between the two lines. Electrophysiology is now Abbott’s second-largest device sub-segment behind Diabetes Care, and its 16.7% reported growth in the first quarter was among the fastest in the portfolio. The Amulet 360 approval is the fourth major electrophysiology regulatory win Abbott has announced in just over a year, following U.S. and European approvals for the Volt pulsed-field ablation system in 2025 and the European approval of the TactiFlex Duo ablation catheter earlier in 2026.

Abbott’s Q1 2026 filing with the SEC is the segment-level record investors use to track whether the electrophysiology growth rate holds as new products launch.

Christopher Piorkowski, M.D., chief medical officer of Abbott’s electrophysiology business, framed the clearance as building on the existing platform: “Amulet 360 builds on the proven legacy of our unique dual-seal design seen in the first-generation LAA occluder, which helped many people with AFib reduce their risk of stroke without the need for long-term blood thinners.”

A questão dos EUA e o que a Marca CE não resolve

A CE Mark permits commercial sale in Europe. It does not resolve the U.S. pathway. The release states plainly that the Amulet 360 is approved for investigational use only in the United States, meaning Abbott will need a separate FDA approval before the device can compete in the American market, where Watchman has held a first-mover position for years. The VERITAS trial was designed as a pivotal study, and its longer-term endpoints, including a composite of ischemic stroke or systemic embolism at 24 months, are the data a U.S. application would rest on.

The clearance also does not by itself change Abbott’s revenue. The company did not disclose a launch price for Amulet 360 or a European sales forecast for the device. Securities.io has tracked Abbott’s device cadence through the year, including its FDA authorization for the Libre Duo glucose-ketone sensor and its settlement of preterm formula claims for $670 million, and the Amulet 360 approval fits the pattern of a company converting a broad pipeline into cleared products across multiple segments.

For the electrophysiology business specifically, the near-term observables are the pace of the European rollout Abbott said will unfold over the coming weeks and any disclosure of when a U.S. regulatory submission might follow the 45-day VERITAS data. The trial’s setembro de 2027 estimated completion date marks the outer boundary of the follow-up evidence the U.S. application will eventually need.