Abbott has received the European CE mark for the Amulet 360, the next-generation version of its device for closing the left atrial appendage, or LAA, in certain patients with atrial fibrillation. The company says the new design is intended to improve the implant’s fit within the appendage and ensure tighter closure, with plans to expand the device’s use in European countries in the coming weeks.
The left atrial appendage is a small pouch in the heart’s upper-left chamber, and it can be a source of clots that cause strokes in patients with atrial fibrillation, a heart rhythm disorder associated with an elevated risk of stroke. Closing the appendage is an option for some patients who cannot tolerate blood-thinning medications, according to the information provided in the article.
Direct Competition in a Market Dominated by Watchman
The approval of Amulet 360 puts Abbott in direct competition with Boston Scientific’s Watchman device, which leads the left atrial appendage closure device market. Abbott CEO Robert Ford said during a call with investors that the market is worth about $2 billion and that the competitor holds a share of up to 90%.
Ford added that the company is focused on taking market share and that the device could support Abbott’s growth in 2027 and beyond. He also described Amulet 360 as a major opportunity for the company, while the article quoted BTIG analyst Marie Thibault as describing the device as a potentially important catalyst for Abbott’s products.
The article indicates that slowing growth in Watchman sales was one of the factors that led Boston Scientific to lower its financial forecasts for 2026 in April and July, after the device’s sales grew by about 30% during 2025.
What Does the New Device Add?
According to Abbott, Amulet 360 was designed to provide physicians with a smoother implantation experience and improve how the device fits within and closes the left atrial appendage. The device met safety and effectiveness criteria in the VERITAS study, which was presented during the 2026 AF Symposium conference, and the company said the study data supported its CE-mark application.
Amulet 360 represents an update to the Amplatzer Amulet device, which has been used in Europe since 2013 and in the United States since 2021. Abbott also completed the submission of an application to the U.S. Food and Drug Administration, FDA, in May to obtain approval for Amulet 360, but the article does not report that the device has received U.S. approval.
Why Does This News Matter?
The event does more than add a new device to the interventional cardiology market; it gives Abbott European regulatory approval for a version on which the company is relying to compete with a dominant product. The only confirmed practical impact at present is that it clears the way for European expansion; the source does not identify the countries where the device will be available or provide details about its price or the timing of its approval in the United States.
Other companies are also active in the same field. Medtronic offers the Penditure system for isolating the left atrial appendage, while AtriCure sells the AtriClip device. Edwards Lifesciences also received FDA authorization for a clip to close the appendage in June. Therefore, the practical significance of Amulet 360 will depend on its use outcomes and adoption by physicians—points that CE approval alone does not resolve.