CE Mark approval for two devices provides new options for hard-to-treat heart valve conditions.

heart valve

Apr 17 2020

Millions of people have heart valve conditions, yet less than 1% receive the standard of care, open-heart surgery, because they’re often too ill or frail for the invasive procedure.1,2,3

Two of Abbott’s newest structural heart devices — the Tendyne* Transcatheter Mitral Valve Implantation System and our TriClip** Transcatheter Tricuspid Valve Repair System — recently received CE Mark approvals and are expected to help fill these gaps in treatment.

Tendyne replaces a leaky mitral valve on the heart’s left side and complements MitraClip, Abbott’s market-leading device for repairing a leaky mitral valve, while TriClip repairs a faulty tricuspid valve on the right side of the heart.

In addition to providing much-needed treatment options, the CE Mark approvals also further boost Abbott’s transcatheter mitral solution portfolio — the world’s largest4 — and potentially broaden the company’s user base.

“We’re entering a renaissance in the treatment of structural heart diseases and Abbott is building the broadest portfolio of structural heart solutions in the world,” said Michael Dale, senior vice president of Abbott’s Structural Heart business.  

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 as the population continues aging.

Abbott’s $1.4 billion in 2019 structural heart sales, highlights the company’s strength in the market as well as its potential to expand. Abbott’s structural heart business has now grown double-digits for the last three years in a row (since the business’s inception).

Expected to help sustain the portfolio’s momentum is Abbott’s robust pipeline, including long-term growth drivers Tendyne and TriClip.

TriClip’s development was inspired by MitraClip’s proven clip-based therapy, but TriClip has a differentiated delivery system uniquely designed for the tricuspid valve. The device clips the leaky tricuspid valve leaflets in place, enabling the valve to close again and the heart to function properly.

Abbott’s Tendyne enables physicians to replace the mitral valve when repair or more invasive surgery aren’t options.

Both Tendyne and TriClip spotlight Abbott’s focus on providing physicians a continuum of care for treating structural heart conditions across diverse patient populations.

“We want to give doctors the options they need to address various structural heart issues,” said Dale.

Visit the company’s structural heart site for a closer look at how Abbott’s game-changing heart tech is helping people live healthier.


For U.S. important safety information on MitraClip, visit:

*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.


1. Nkomo, et al. Burden of valvular heart diseases. Lancet. 2006.

2. U.S. Census Bureau. Statistical Abstract of the United States: 2012. Table 7.

3. Stuge O, Liddicoat J. Eme rging opportunities for cardiac surgeons within structural heart disease. J Thorac Cardiovasc Surg. 2006;132:1258–126.

4. Internal data at Abbott.


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