In a significant development for cardiology, the U.S. Food and Drug Administration (FDA) has approved the TriClip device for transcatheter edge-to-edge repair (TEER) in patients with tricuspid regurgitation (TR) who are not candidates for traditional surgery. The announcement, made by the manufacturer Abbott, marks a major milestone in the treatment of this condition.

What is the TriClip Device?

The TriClip device is designed for patients with tricuspid regurgitation, a condition where the tricuspid valve fails to close properly, leading to problematic blood flow. This device provides an alternative for those unable to undergo open-heart surgery due to age or other health concerns. By utilizing TEER, TriClip improves valve function without the need for high-risk surgical interventions.

Key Approval Insights

In February, the FDA’s Circulatory System Devices Panel voted decisively on the TriClip’s approval, with a 12-2 vote in favor of its efficacy and a unanimous 14-0 vote on its safety. This decision was supported by robust data from the TRILUMINATE pivotal trial. The trial demonstrated that patients treated with TriClip experienced more favorable outcomes compared to those receiving medical therapy alone. Specifically, TriClip patients showed improved primary composite outcomes, including reduced all-cause mortality, decreased need for tricuspid valve surgery, fewer hospitalizations for heart failure, and better overall quality of life after one year.

Participants in the TRILUMINATE trial had severe tricuspid regurgitation and were at intermediate risk for mortality from traditional valve surgery. They were stable on guideline-directed medical therapy and/or device therapy for heart failure.

Expert Opinions

Dr. Paul Sorajja, co-principal investigator of the TRILUMINATE trial, highlighted the significance of the FDA approval: “This advancement represents a crucial option for patients with tricuspid regurgitation, allowing for improved valve function without the risks associated with open-heart surgery. This is particularly important for older and sicker patients who may not be suitable candidates for conventional surgery.”

Dr. David Adams, another co-principal investigator, remarked on the broader implications of the approval: “The introduction of TriClip signals the beginning of a new era in tricuspid valve intervention. This development is likely to lead to earlier treatment of TR in patients who have not responded to medical therapy, potentially resulting in even better outcomes.”

Global and Domestic Perspectives

The TriClip device has been available in over 50 countries since receiving CE Mark approval in 2020. With its recent FDA approval, it is expected to make a substantial impact in the U.S. as well.

The approval of both TriClip and the Evoque device, the first transcatheter tricuspid valve replacement option, in the U.S. sets the stage for a dynamic period in the field. Dr. Adams noted that heart teams will need to carefully evaluate patients, considering their tricuspid anatomy to determine the best treatment strategy. He anticipates that, similar to practices in Europe, TEER will be tried first, with valve replacement considered if necessary.

While Evoque received approval based on preliminary data and without an advisory committee review, TriClip’s approval was based on comprehensive trial results from TRILUMINATE. The FDA labeling for TriClip specifies its use for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation who are at intermediate or higher risk for surgery.

Looking Ahead

The introduction of both TriClip and Evoque offers new treatment options for patients with tricuspid regurgitation. As the field evolves, heart teams will need to navigate these options to achieve the best outcomes for their patients. Dr. Adams believes that while the indications for these devices may differ, the patient population treated by both will likely overlap. TriClip may often be preferred if it is a viable option, with valve replacement considered if symptoms persist after TEER.

This approval marks just the beginning of advancements in tricuspid regurgitation treatment, and the coming years are expected to bring further developments and improvements in patient care.