Dive Brief:
- Abbott has received Europe’s CE mark for the next-generation version of its Amulet device. The implant seals the heart’s left atrial appendage, or LAA, to help reduce the risk of stroke in people with atrial fibrillation.
- The device has been designed to improve how the implant conforms to and seals the LAA, the company said Thursday. Abbott plans to expand use of the new device, called Amulet 360, across European countries in the coming weeks.
- Amulet competes with Boston Scientific’s market-leading Watchman LAA closure device. Softer Watchman sales growth was a factor prompting Boston Scientific to cut its 2026 financial forecast in both April and July, after the device’s sales grew at a rate of nearly 30% in 2025.
Dive Insight:
Heart device makers have stepped up investment in LAA treatments in recent years to address the large number of people with AFib. Medtronic also offers the Penditure LAA exclusion system, and AtriCure sells the AtriClip. Edwards Lifesciences received Food and Drug Administration clearance for a LAA clip device in June.
The LAA, a small pouch in the heart’s upper left chamber, is a source of stroke-causing blood clots in patients with AFib, an irregular heart rhythm that increases stroke risk. Sealing off the LAA is an option for AFib patients who can’t tolerate blood thinners to help prevent a stroke.
On Abbott’s earnings call last month, BTIG analyst Marie Thibault called Amulet 360 an “exciting product catalyst” for the company.
Abbott CEO Robert Ford said on the call that LAA closure is a $2 billion market, and the company’s competitor has a 90% share. Amulet 360 is designed to provide a more “seamless implant experience” for the physician, Ford said, and he expects the device to drive growth for Abbott in 2027 and beyond.
“My focus, and the team’s focus here, is on market share capture. I think this represents a big opportunity for us,” the CEO told investors. “Data and feedback from Amulet 360 has been fantastic.”
Amulet 360 met benchmarks for safety and effectiveness in the VERITAS study presented at the 2026 AF Symposium. Abbott said the data supported its CE mark.
The device is an updated version of Abbott’s Amplatzer Amulet that has been in use in Europe since 2013 and in the U.S. since 2021. In May, Abbott also completed a submission to the FDA for Amulet 360.
