Abbott's structural heart portfolio has reached new heights with recent U.S. Food and Drug Administration (FDA) approval of two key minimally invasive devices — the Amplatzer Amulet Left Atrial Appendage (LAA) Occluder and Portico with FlexNav transcatheter aortic valve replacement (TAVR) system.
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 atrial fibrillation (AFib), brings competition to the more than $500 million U.S. LAA market,1 which — up until now — has been a single-product market.
Portico, helping open a narrowed aortic valve in people with aortic stenosis, one of the most common and life-threatening heart valve diseases, bolsters Abbott's heart valve device offerings.
Together, these two recent approvals solidify Abbott's structural heart portfolio as the most comprehensive in the U.S.2
Adding to Abbott's momentum are recent data that show Amulet has superior closure and noninferior safety and effectiveness in LAA closure to a competitor device. The findings come from a much-anticipated, head-to-head study comparing Amulet with the competitor product.
"With the introduction of Amulet and Portico with FlexNav in the U.S., physicians now have access to an even more robust set of solutions to treat structural heart disease," said Michael Dale, senior vice president of Abbott's Structural Heart business.
Amulet's Competitive Advantage
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),3 the FDA approval of Amulet also boosts Abbott's structural heart portfolio 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 and Portico are significant milestones that improve upon the currently available treatment options to restore health and improve quality of life so more people with structural heart diseases can get back to living fuller lives," Dale said.
"We've been marching toward this moment since forming our dedicated structural heart division and our Amulet and Portico devices make important additions to our portfolio."
Learn more about Amulet, including the latest data on the device, and get details on Portico.
*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.
1Cowen, Ahead of the Curve Series: ABT to Join BSX in the U.S. Market for Left Atrial Appendage Closure, June 30, 2021.
2Internal data at Abbott.
3Circulation Research, Kornej et al., "Epidemiology of Atrial Fibrillation in the 21st Century," June 18, 2020.
This story was originally published on August 17, 2021. It was updated on August 30, 2021 to reflect the announcement of new data. And it was updated on October 5, 2021 to reflect FDA approval of Portico.