Abbott’s Tendyne TMVR System has received FDA approval, offering a minimally invasive solution for patients with severe mitral annular calcification who aren’t eligible for open-heart surgery. As heart disease remains the world’s leading cause of death, this marks a major step forward in expanding access to life-saving mitral valve replacement options.
Wish to Learn More About The Global Cardiac Surgery Market?
Get a complimentary report summary today:
Table of Contents
➜ What Is Abbott’s Tendyne TMVR System?
➜ What Is the Significance of Tendyne TMVR FDA Approval?
↳ Why Abbott’s Tendyne TMVR System FDA Approval Matters
↳ Why Tendyne is a Breakthrough
➜ Who Benefits from the Tendyne TMVR System?
➜ How Does Tendyne Compare to Other Mitral Valve Therapies?
➜ Get a Complimentary Cardiac Report Summary
Key Takeaways
- FDA Approval: Abbott’s Tendyne TMVR system has received FDA approval for treating patients with severe mitral annular calcification (MAC) who are at high risk for open-heart surgery.
- Patient Impact: The Tendyne system provides a minimally invasive alternative for patients ineligible for traditional surgical or transcatheter mitral valve repair, addressing a significant unmet need in cardiac care.
- Device Features: Tendyne’s self-expanding valve is available in multiple sizes, accommodating various patient anatomies, and is fully repositionable and retrievable during implantation.
What Is Abbott’s Tendyne TMVR System?
The Tendyne Transcatheter Mitral Valve Replacement (TMVR) system is a minimally invasive device designed to replace the mitral valve in patients with severe mitral annular calcification (MAC).
Unlike traditional open-heart surgery, Tendyne is delivered through a small incision in the chest, reducing recovery time and surgical risks.
The device features a self-expanding valve that conforms to the patient’s anatomy and can be repositioned or retrieved during the procedure, enhancing procedural safety and efficacy.
📌 Find Out More About TAVI & TMVR. Read:
➜ Minimally Invasive Heart Surgery: Can TAVI & TMVr Replace Open Surgery for Good?
What Is the Significance of Tendyne TMVR FDA Approval?
The FDA approval of Tendyne offers a new treatment avenue for a patient group with previously limited options. With cardiovascular disease remaining the leading cause of death in the United States, innovations like Tendyne are crucial in improving patient outcomes and expanding access to life-saving therapies.
Why Abbott’s Tendyne TMVR System FDA Approval Matters
- Mitral regurgitation, which Tendyne is designed to treat, affects more than 4 million Americans, yet many are considered too high-risk for traditional open-heart mitral valve replacement due to age, comorbidities, or anatomical challenges like mitral annular calcification (MAC). Mitral annular calcification is when calcium builds up around the mitral valve, making it harder for the valve to open and close properly, which can affect blood flow in the heart.
- According to the American Heart Association (AHA), 1 in 4 deaths in the U.S. is caused by cardiovascular disease, with heart valve disorders among the leading contributors to heart failure-related hospitalizations in adults over 65.
- The AHA’s 2025 update reports over 60,000 people die from heart valve disease (HVD) in the U.S. each year.
- Mortality for untreated severe mitral valve disease can exceed 50% within 5 years, underscoring the urgency for alternatives like Tendyne.
Why Tendyne is a Breakthrough
Most patients with severe mitral annular calcification (MAC) have historically been excluded from surgical or transcatheter repair options due to the risk of complications. Tendyne provides a fully repositionable and retrievable valve, implanted via a minimally invasive transapical approach, which reduces surgical trauma and broadens eligibility for intervention.
Its approval gives physicians a new tool in managing a challenging patient group, and signals a future where customized, catheter-based heart valve solutions may become standard of care.
📌 Learn More About Cardiac Innovations. Read:
➜ Heart Care Innovations: Laser Atherectomy & Drug-Coated Balloons Explained
Who Benefits from the Tendyne TMVR System?
Tendyne is specifically approved for patients with severe mitral annular calcification (MAC) who are considered high-risk candidates for open-heart surgery and are not suitable for transcatheter mitral valve repair procedures like Abbott’s MitraClip.
This patient population often has limited treatment options, and Tendyne offers a viable alternative that can alleviate symptoms such as shortness of breath, fatigue, and heart failure.
📌 Learn More About Modern Open Heart Surgery. Read:
How Does Tendyne Compare to Other Mitral Valve Therapies?
| Feature | Tendyne TMVR System | MitraClip (TEER) |
| Approach | Valve replacement | Valve repair (edge-to-edge) |
| Indication | Severe MAC, high surgical risk | Select MR patients, less MAC |
| Suitability for Severe MAC | Yes | No |
| Repositionable/Retrievable | Yes | No |
| Minimally Invasive | Yes (transapical approach) | Yes (transcatheter) |
| FDA Approval (as of 2025) | Yes (for severe MAC, high risk) | Yes (for select MR patients) |
Prior to Tendyne’s approval, treatment options for patients with severe MAC were limited. While devices like the MitraClip are effective for certain mitral valve conditions, they are not suitable for all patients, particularly those with extensive calcification. Tendyne fills this therapeutic gap by providing a replacement option rather than a repair, expanding the range of patients who can benefit from minimally invasive mitral valve interventions.
Get a Complimentary Cardiac Report Summary
Overall, the global cardiac surgery device market was valued at $17.1 billion in 2023. This is expected to increase over the forecast period at a CAGR of 5.5% to reach $24.9 billion. Currently, the majority of the global market share is controlled by three main companies – Edwards Lifesciences, Abbott, and Medtronic.
For an in-depth understanding of these trends, delve into our detailed 2024–2030 Global Cardiac Surgery Market Report. This report offers a comprehensive analysis of the Global Cardiac Surgery Market, covering:
- Heart Valves: Tissue, Mechanical, Transcatheter Mitral Repair & Replacement.
- Surgical Devices: Coronary Bypass (ONCAB/OPCAB), Autotransfusion, Anastomosis Assist, Embolic Protection, Vessel Harvesting, Balloon Valvuloplasty.
- Assistive Devices: Ventricular Assist, Intra-Aortic Balloon, Artificial Heart.
- Closure Devices: Septal, Foramen Ovale, Ductus Arteriosus, Left Atrial Appendage.
- Technologies: Guidewire, Revascularization, ECMO and more.
Or request a complimentary Global Cardiac Surgery Market Report Executive Summary – completely free.
