Abbott has an exciting structural heart portfolio opportunity with the U.S. Food and Drug Administration approval of its minimally invasive Amplatzer Amulet Left Atrial Appendage (LAA) Occluder for people with atrial fibrillation (AFib). Amulet, which closes the left atrial appendage (a small pouch connected to the heart's upper left chamber) to help prevent blood clots and reduce stroke risk in people with AFib, brings competition to the $500 million U.S. LAA market,1 which — up until now — has been a single-product market. Adding to Abbott's momentum are new data that show Amulet has superior closure and noninferior safety and effectiveness in LAA closure to the other device on the market. The findings come from a much-anticipated, head-to-head study comparing Amulet with the competitor product. Abbott's Amulet — already a market leader in Europe, the Middle East and Asia — stands out from the competition with its dual-seal technology, completely and immediately sealing the LAA to help prevent blood clots from traveling to the brain and causing a stroke. Thanks to the dual seal, people with Amulet don't need to use blood-thinning medication (which can increase risk of major bleeding) once they've had the procedure. In addition to providing much-needed treatment options, as the nation's aging population contributes to a rise in AFib cases (up to 6 million people in the U.S. have the condition, surging to potentially 16 million by 2050),2 the FDA approval of Amulet also boosts Abbott's structural heart portfolio — the broadest in the U.S.3 — and is expected to expand the company's user base. 'We believe Amulet will become a needle-moving product that will help sustain the elite high-single-digit organic revenue growth profile of the Medical Devices business,' wrote Cowen analysts in a recent report.1 Breadth of Portfolio Structural heart conditions refer to defects or abnormalities in the heart's valves, walls and/or muscle. These heart problems affect tens of millions of people worldwide, and that number's projected to grow with the aging population. Abbott's Structural Heart business contributes more than a billion dollars in sales every year, highlighting the company's strength in the market as well as its potential to expand. Expected to help sustain the portfolio's momentum is Abbott's robust pipeline, including valve solutions Tendyne* and TriClip,** along with the company's market-leading MitraClip device. 'The FDA's approval of Amulet is a significant milestone in allowing us to bring this therapy to American physicians and patients, and improves upon the currently available treatment option to provide people even greater peace of mind against stroke risk,' said Michael Dale, senior vice president of Abbott's Structural Heart business. 'We've been marching toward this moment since forming our dedicated structural heart division and our Amulet device makes an important addition to our portfolio.' Learn more about Amulet and the latest data. *The Tendyne Transcatheter Mitral Valve Implantation System is an investigational device only in the U.S. **The TriClip Transcatheter Tricuspid Valve Repair System is an investigational device only in the U.S. References 1Cowen, Ahead of the Curve Series: ABT to Join BSX in the U.S. Market for Left Atrial Appendage Closure, June 30, 2021. 2Circulation Research, Kornej et al., 'Epidemiology of Atrial Fibrillation in the 21st Century,' June 18, 2020 3Internal data at Abbott. This story was originally published on August 17, 2021. It was updated on August 30, 2021 to reflect the announcement of new data.