Abbott announced on Tuesday that it had received FDA approval for its Tendyne transcatheter mitral valve replacement system. This is the first device capable of replacing mitral valves without open-heart surgery.
The device addresses a critical treatment gap for patients with severe mitral annular calcification who face high surgical risks. These patients previously had limited options when traditional repair methods failed.
Mitral annular calcification (MAC) involves calcium buildup around the valve’s supporting structure, causing the valve to leak or narrow. This condition disrupts normal blood flow and can severely impact quality of life.
“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,” said Dr. Paul Sorajja, director of the Center for Valve and Structural Heart Disease at Minneapolis Heart Institute. “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.”
The Tendyne system offers a minimally invasive alternative for high-risk patients. It is designed for those whose valves cannot be successfully repaired with Abbott’s existing MitraClip device.
The self-expanding valve is delivered through a small chest incision rather than requiring open-heart surgery. Once positioned, it can be repositioned or retrieved during implantation to optimize placement.
Sorajja emphasized the importance of the device in challenging cases.
“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,” he said.
The system’s unique design accommodates various patient anatomies through multiple available sizes. This flexibility allows doctors to tailor treatment to individual patient needs.
“Tendyne bridges a critical treatment gap for these patients and can help reduce the symptoms that can interfere with their lives,” Sorajja added.
Sandra Lesenfants, senior vice president of Abbott’s structural heart business, highlighted the device’s strategic importance.
“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,” she said.
The approval builds on Abbott’s history in mitral valve innovation. The company previously developed the MitraClip, another first-of-its-kind device for valve repair.
“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,” Lesenfants said.
Abbott’s structural heart portfolio now includes both repair and replacement options for mitral valve disease. This comprehensive approach addresses varying patient needs and anatomical challenges.
The FDA approval represents a significant milestone for many patients with complex mitral valve conditions who previously faced limited treatment options due to surgical risks or anatomical constraints.