The FDA has approved Abbott’s Tendyne device, a first-of-its-kind system designed to replace the mitral valve without the need for open-heart surgery.
Tendyne provides a treatment option for patients with severe mitral annular calcification (MAC), a condition caused by calcium buildup in the ring-like base of the mitral valve. This buildup can lead to significant mitral regurgitation (MR), where blood flows backward through the valve, or stenosis, where the valve becomes narrowed and restricts blood flow.
Mitral valve disease can severely impact a patient’s ability to breathe and exercise, often causing fatigue, chest pain and dizziness. For patients with severe MAC who are at high risk for traditional surgery, Tendyne’s approach — delivering the new valve while the heart is still beating — avoids the need for cardiopulmonary bypass or rapid pacing.
The Tendyne system was evaluated in a global clinical study of 100 patients. At two years, 93.2% of surviving patients had no residual MR, while the rest had only mild leakage. Most patients improved to the mildest categories (known as New York Heart Association class I or II) of heart failure symptoms, compared to a baseline where 66% were in class III or IV, meaning they had severe limitations in daily activities or symptoms even at rest. Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, which measure a patient’s perception of their heart-related quality of life, rose from 49 to 67 points (out of 100).
The number of hospital visits for worsening heart failure dropped by more than half, from an average of 1.3 to 0.51 events per year. Right ventricular systolic pressure decreased from 47.6 to 32.5 mm Hg at two years, and no structural valve deterioration was observed during follow-up.
The estimated two-year all-cause mortality rate was 41.6%, with nearly half of these deaths occurring within the first 90 days following the procedure, reflecting the severity of disease in this high-risk group. Device-related complications, such as migration or major bleeding, were less common after the first year of use.
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The Tendyne valve’s self-expanding design allows it to be fully repositioned and retrieved during implantation, enabling a tailored fit for each patient. With multiple valve sizes ranging from 29 mm to 39 mm, the system is designed to accommodate a wide range of patient anatomies.
Abbott plans to continue advancing its structural heart portfolio, further refining treatments like Tendyne that prioritize patient needs and quality of life. With this FDA approval, patients in the US with severe MAC now have a new option to restore their health without open-heart surgery.
By 2029, the volume of cardiac surgeries in the US is expected to reach 1.3 million procedures, reflecting the aging population’s needs and the increasing adoption of transcatheter valve replacements over open-heart surgery.
The transcatheter heart valve market continues to see advances in valve design, materials and delivery systems, with a focus on improving durability and ease of implantation. Minimally invasive approaches are gaining preference because they offer shorter recovery times, lower procedural risks and reduced healthcare costs compared to traditional surgery. While transcatheter aortic valve replacements currently lead the market, the transcatheter mitral valve segment is expected to grow at the fastest rate.
The global heart valve devices market is forecasted to expand at a compound annual growth rate (CAGR) of 11.7% through 2034, fueled by the growing prevalence of heart disease worldwide, an aging demographic and a preference for minimally invasive interventions.
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