Abbott Taps Growing TMVR Market With Tendyne System

Abbott Laboratories ABT recently received Food and Drug Administration (“FDA”) approval for its Tendyne transcatheter mitral valve replacement (TMVR) system. The Tendyne system replaces mitral valves that are not functioning properly due to severe mitral annular calcification (MAC). The Tendyne system expands the company’s comprehensive Structural Heart portfolio.

The rising prevalence of mitral valve diseases, growing preferences for minimally invasive procedures and expanding geriatric population has driven the adoption of TMVR system. Investors are eyeing this fast-growing market, which is projected to witness a compound annual growth rate of 20% from 2025 to 2030 (Per a Medi-Tech Insights report).

MAC stiffens the structure of the mitral valve and can lead to mitral regurgitation or stenosis that disrupts the heart's ability to pump blood effectively. The complex nature of this mitral valve disease and patients' specific needs and health conditions can pose challenges for surgical correction. The Tendyne system offers an alternative, minimally invasive way to replace the valve of patients with severe MAC who are at high risk for open-heart surgery.

The innovative and unique design of the Tendyne system and the valve's availability in multiple sizes allow 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.

Offerings By ABT’s Peers in the Structural Heart Field

Edwards Lifesciences EW makes significant investments in the development of transcatheter heart valve repair and replacement technologies designed to treat mitral and tricuspid valve diseases. The company’s PASCAL Precision system addresses the needs of patients with mitral or tricuspid regurgitation through leaflet approximation. The EVOQUE system is the world's first transcatheter tricuspid valve replacement therapy to receive regulatory approval. It addresses tricuspid valve regurgitation by replacing the native valve with a bioprosthetic valve. In addition, SAPIEN M3 transcatheter mitral valve replacement system is designed specifically for patients with symptomatic mitral regurgitation.

Medtronic’s MDT Structural Heart & Aortic division offers therapies for heart valve disorders and aortic disease. Key products include the CoreValve family (Evolut PRO, PRO+, FX, FX+ TAVR systems), surgical valve replacement and repair solutions (tissue and mechanical), blood-handling systems, surgical ablation technologies, and positioning/stabilization tools. The company also provides endovascular stent grafts and accessories like the Endurant II Stent Graft System (abdominal aortic aneurysms), Valiant Captivia Thoracic Stent Graft System (thoracic repair) and Heli-FX EndoAnchor System.

ABT Price Performance

In the past year, Abbott shares have surged 19.2%, outperforming the industry’s 6.2% growth. The S&P 500 composite grew 17.8% in the same period.

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Discounted Valuation

ABT currently trades at a forward 12-month Price-to-Sales (P/S) of 4.87X compared with the industry average of 5.56X.

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ABT Stock Estimate Trend

In the past 30 days, Tempus AI's EPS estimate has moved south 0.2% for 2025.

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ABT stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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