About NaviGate CSI

Given the unmet clinical need for patients with moderate or greater functional valve regurgitation (FTR)/ tricuspid insufficiency, NCSI is developing a catheter-guided atrioventricular valved stent for replacement of a failing tricuspid valve. Innovative anchoring mechanisms serve to secure and maintain positioning of the replacement valve.

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The Technology

The GATE™ System is designed to provide a novel, bio-prosthetic solution for treatment of moderate or greater functional tricuspid regurgitation.


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Tricuspid regurgitation (insufficiency) is a clinical condition that affects millions of people worldwide. While citations in the literature estimated that more than 1.6 million Americans had moderate to severe tricuspid regurgitation in 2006, data presented by key opinion leaders in 2018 estimate that as many as 2.5 million Americans may now be affected.

NCSI is developing a solution for heart teams to treat tricuspid regurgitation/insufficiency through valve replacement.

Early clinical studies in humans are anticipated to begin in Summer 2019.

Our Mission

The mission of NaviGate Cardiac Structures, Inc., is to be the leader in development of innovative transcatheter bioprosthetic heart valve implants for treating the unmet needs of atrioventricular valve disease.

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