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.
The GATE™ System is designed to provide a novel, bio-prosthetic solution for treatment of moderate or greater functional tricuspid regurgitation.
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.
Clinical use of the device under the early feasibility study is anticipated to begin at multiple centers under a common protocol in early 2020.
To be the leader in developing a transcatheter tricuspid valve replacement technology to treat functional tricuspid regurgitation.
In the News
An Early Feasibility Study (EFS) for NCSI’s GATE™ system was approved by the U.S. Food and Drug Administration (FDA) on 22 November 2019 to evaluate the safety and short-term efficacy of the device. Data from the EFS is further intended to support expansion under a...
At the end of 2018, iVascular SLU, a European medical device company, made an investment in NaviGate Cardiac Structures, Inc. and will be instrumental in helping the company’s developments by providing its expertise in fabrication and manufacturing of various...
Communiqué de presse PREMIÈRE MÉDICALE CANADIENNE : UN 10E CAS DE REMPLACEMENT TRICUSPIDE PERCUTANÉ AU MONDE RÉALISÉ À L’INSTITUT Québec, 8 février 2018 – L’Institut universitaire de cardiologie et de pneumologie de Québec– Université Laval (l’Institut) a récemment...