The technology recently received U.S. Food and Drug Administration (FDA) approval. The first procedure was conducted by Paul Sorajja, MD, director of the Center for Valve and Structural Heart Disease for Allina Health Minneapolis Heart Institute®, Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation (MHIF), and global principal investigator of the TRILUMINATE™ Pivotal Trial, which was part of the data reviewed by the U.S. FDA. Dr. Sorajja completed the first procedure at Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital on Apr. 4.
“This is a major win for the more than 1 million Americans whose lives are impacted by tricuspid regurgitation. Those who have this leaky valve condition often suffer from shortness of breath, fatigue and have a greater risk of serious health issues,” said Dr. Sorajja. “We have seen impressive results with TriClip during the trial as it limits leakage and improves quality of life for our patients without the need for open-heart surgery. Many TR patients are older and therefore a high-risk surgery is not a viable option. The TriClip is a much less invasive procedure.”
A significant portion of the research data that was reviewed by the U.S. FDA was led by Dr. Sorajja at the Minneapolis Heart Institute Foundation (MHIF), which was the top enroller (enrolling 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. MHIF research was done at Allina Health’s Abbott Northwestern Hospital led by Dr. Sorajja and a team with a depth of expertise in advancing the treatment of TR.
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.
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 quality of life for patients.
Abbott recently announced that the TriClip TEER system received FDA approval.
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