Abbott Receives FDA Approval for Tendyne™, First-of-Its-Kind Device to Replace the Mitral Valve Without Open-Heart Surgery

Rhea-AI Summary

Abbott (ABT) has received FDA approval for its Tendyne™ transcatheter mitral valve replacement (TMVR) system, a first-of-its-kind device that replaces malfunctioning mitral valves without open-heart surgery. The system is specifically designed for patients with severe mitral annular calcification (MAC) who are high-risk candidates for traditional surgery.

The innovative Tendyne system features a self-expanding valve that is delivered through a small chest incision and is fully repositionable during implantation. The device is available in multiple sizes to accommodate different patient anatomies and offers a new treatment option for patients who cannot undergo open-heart surgery or mitral repair with Abbott's MitraClip™ device.

Positive

• First FDA-approved device for transcatheter mitral valve replacement without open-heart surgery
• Expands Abbott's portfolio of minimally invasive structural heart therapies
• Addresses an unmet medical need for high-risk patients with severe MAC
• Features fully repositionable and retrievable valve design for optimal outcomes
• Available in multiple sizes to adapt to different patient anatomies

Negative

• None.

Insights

Medical Device Regulatory Expert

Abbott's FDA approval for Tendyne creates first-to-market advantage in a significant untreated patient population with mitral valve disease.

Abbott's FDA approval for the Tendyne™ TMVR system represents a significant advancement in the treatment landscape for mitral valve disease. This first-of-its-kind device addresses a critical unmet need for patients with severe mitral annular calcification (MAC) who are poor candidates for conventional open-heart surgery or mitral valve repair procedures.

The strategic importance of this approval cannot be overstated. It positions Abbott as the only company with an FDA-approved transcatheter solution specifically for MAC patients, a notoriously difficult-to-treat population that has limited therapeutic options. By targeting this specific pathology, Abbott has effectively created a new market segment within the structural heart space.

The Tendyne system's design features provide important clinical advantages. Its self-expanding valve with multiple size options accommodates diverse patient anatomies. The fully repositionable and retrievable capability during implantation enhances procedural safety and precision, likely translating to better patient outcomes. These features differentiate it from other valvular interventions and support premium pricing potential.

This approval complements Abbott's existing MitraClip™ system, creating a comprehensive mitral valve portfolio that now addresses both repair and replacement through minimally invasive approaches. This portfolio breadth strengthens Abbott's competitive position against other structural heart companies and provides physicians with a complete toolkit for mitral valve disease management.

Interventional Cardiologist

Tendyne approval addresses critical treatment gap for high-risk MAC patients, expanding Abbott's mitral valve dominance beyond MitraClip.

The FDA approval of Abbott's Tendyne™ TMVR system represents a game-changing development for patients with severe mitral annular calcification (MAC). MAC creates uniquely challenging treatment scenarios as the calcification prevents proper valve function and simultaneously makes conventional surgical approaches extremely high-risk.

From a technical perspective, the Tendyne system's design offers key clinical advantages. The self-expanding valve delivered through a small chest incision navigates the complex anatomy of calcified mitral annuli more effectively than traditional approaches. The system's repositionability and retrievability during deployment are crucial safety features that allow operators to optimize placement in these anatomically challenging cases.

What's particularly significant is how this approval fills a specific treatment gap. For years, clinicians have struggled with MAC patients who weren't candidates for MitraClip repair (due to valve anatomy) or conventional surgery (due to excessive risk). These patients typically faced conservative medical management with poor outcomes. Tendyne creates a viable alternative for this orphaned patient population.

The approval also strengthens Abbott's already dominant position in the mitral valve space. With both MitraClip for repair and now Tendyne for replacement, Abbott offers comprehensive solutions across the spectrum of mitral valve disease. This portfolio breadth creates significant clinical advantages for integrated heart valve programs looking to streamline their structural heart inventory while maximizing treatment options.

• The Tendyne system replaces mitral valves that are not functioning properly due to a buildup of calcium in the base of the valves, known as severe mitral annular calcification (MAC)
• Tendyne offers a new treatment option for patients who are not candidates for open-heart surgery or mitral repair
• This approval expands Abbott's portfolio of minimally invasive structural heart therapies in the U.S.

ABBOTT PARK, Ill., May 27, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved the company's Tendyne™ transcatheter mitral valve replacement (TMVR) system to treat people with mitral valve disease. This life-changing therapy is available for patients whose mitral valves are not functioning properly due to severe mitral annular calcification (MAC), a buildup of calcium within the ring-like structure (known as an annulus) that supports the mitral valve.

The complex nature of mitral valve disease and patients' specific needs and health conditions can pose challenges for surgical correction. For patients with severe MAC who are at high risk for open-heart surgery and whose mitral valve cannot be successfully repaired with the Abbott MitraClip™ device, Tendyne offers an alternative minimally invasive way to replace the valve that's leaky (mitral regurgitation) or narrowed (stenosis).

"Mitral annular calcification stiffens the structure of the mitral valve and can lead to mitral regurgitation or stenosis that disrupt the heart's ability to pump blood effectively. These conditions can have a significant impact on a patient's quality of life, causing symptoms such as chest pains, shortness of breath and dizziness," said Paul Sorajja, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital. "Unfortunately, patients with MAC can be very difficult to operate on and many are considered too high risk for open-heart surgery due to multiple co-morbidities or other factors. Tendyne bridges a critical treatment gap for these patients and can help reduce the symptoms that can interfere with their lives."

The innovative and unique design of the Abbott Tendyne system and the valve's availability in multiple sizes allows it to adapt to a range of patient anatomies. The self-expanding valve is delivered through a small incision in the chest and then advanced into the heart to replace the mitral valve. The valve is fully repositionable and retrievable during implantation, allowing for the best possible outcome for people requiring a valve replacement.

"Tendyne is a much-needed addition to our comprehensive U.S. structural heart portfolio that offers less invasive treatment options for a range of heart diseases," said Sandra Lesenfants, senior vice president of Abbott's structural heart business. "This approval builds on our more than two decades of mitral valve leadership that includes developing first-of-their-kind devices that truly change – and save – people's lives."

For U.S. important safety information about Tendyne, visit https://abbo.tt/TendyneISI.

For U.S. important safety information about MitraClip, visit https://abbo.tt/MitraClipISI.

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.

 

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SOURCE Abbott

FAQ

What is Abbott's Tendyne device and what FDA approval did it receive?

Tendyne is Abbott's transcatheter mitral valve replacement system that received FDA approval to treat mitral valve disease in patients with severe mitral annular calcification (MAC) who cannot undergo open-heart surgery.

How does the Abbott Tendyne TMVR system work?

The Tendyne system uses a self-expanding valve that is delivered through a small chest incision and advanced into the heart to replace the mitral valve. It is fully repositionable during implantation for optimal placement.

Who are the ideal candidates for Abbott's Tendyne valve replacement?

Tendyne is designed for patients with severe mitral annular calcification (MAC) who are high-risk candidates for open-heart surgery and cannot be treated with Abbott's MitraClip device.

What are the key benefits of Abbott's Tendyne TMVR system?

Key benefits include minimally invasive procedure without open-heart surgery, multiple size options for different anatomies, and full repositionability during implantation for optimal outcomes.

What conditions does Abbott's Tendyne treat in heart patients?

Tendyne treats mitral valve disease, specifically addressing leaky valves (mitral regurgitation) or narrowed valves (stenosis) caused by severe mitral annular calcification (MAC).