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Today, a new therapy is available for patients following years of lifesaving heart research.
Minneapolis Heart Institute Foundation® (MHIF) announced an important research milestone with the U.S. Food and Drug Administration (FDA) approval of the TriClip™ (manufactured by Abbott). See our official announcement.
TriClip is a first-of-its-kind, minimally invasive clip-based device that is specifically designed for the tricuspid valve, which is often referred to as the “forgotten valve” due to historically limited treatment options. It's a therapy for patients with a leaky tricuspid valve, a condition known as tricuspid regurgitation (TR).
"We are proud to be the leading center contributing significant research to this important new treatment option for patients who are living with tricuspid regurgitation, a heart condition that negatively affects quality of life and puts them at grave rise of serious health issues,” said Paul Sorajja, MD, the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for MHIF, director of the Center for Valve and Structural Heart Disease for Allina Health Minneapolis Heart Institute®, and global principal investigator of the TRILUMINATE Pivotal trial. "We developed a depth of understanding and expertise in the use of the new repair technology. We celebrate this research milestone and the FDA approval, which expands access to an advanced treatment option backed by excellent safety and effectiveness to help restore tricuspid valve performance without high-risk open-heart surgery."
TriClip is delivered to the heart via a catheter inserted through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood.
Designed specifically for the right side of the heart and the tricuspid valve’s complex anatomy, the innovative TriClip and steerable guiding catheter systems allow physicians to independently grasp and effectively clip leaflets of the tricuspid valve to reduce the regurgitation. This minimally invasive approach allows the heart to pump blood more efficiently and relieve symptoms of TR, which improves the quality of life for patients.
About Tricuspid Regurgitation (leaky tricuspid heart valve)
Tricuspid valve regurgitation is a condition in which the valve between the two right heart chambers (right ventricle and right atrium) don’t close properly, allowing blood to flow backward into the right atrium of the heart. The disease is often debilitating, causing symptoms such as shortness of breath and fatigue, and when left untreated, may progress into conditions such as atrial fibrillation (AF), heart failure and, ultimately death.
Traditionally, the only treatment options for TR have been surgery, which is rarely performed due to the complexity of the procedure and high risks involved, and medical therapy, which is usually not successful in reducing TR. Abbott’s TriClip device provides a much-needed treatment option for people suffering from this condition.
Patients are at the heart of our mission – leading world-class cardiovascular research and education to improve care for patients around the world. MHIF was a significant contributor to the research that led to the approval for this new treatment option.
- MHIF enrolled the first and largest number of patients of all 68 clinical sites participating in the TRILUMINATE™ Pivotal trial in the United States, Canada and Europe.
- MHIF led the way as the first to provide this technology to a patient as part of an early research study in 2017 and completed the first-in-the-world enrollment in the pivotal trial in August 2019.
