Developed and produced by NCSI, the GATE tricuspid atrioventricular valved stent (AVS) will be used to capture the enlarged annulus in patients suffering from functional tricuspid regurgitation (FTR).

Cleveland Clinic’s cardiac team has implanted the AVS with catheter-guided technique under a compassionate plea from the patient.

According to the company, the valve demonstrated better valvular function after the implantation, indicating correction of the massive regurgitation problem.

NaviGate used Cleveland Clinic’s seminal technology in the development of Gate tricuspid AVS, which is claimed to be the world’s first transcatheter tricuspid valved stent.

The technology platform is comprised of percutaneous valve devices for mitral valve replacement and tissue-preservation techniques that remove the toxic tissue fixatives.

NaviGate’s scientific advisory board member Dr Jose Navia said: “This is a step forward in the treatment of tricuspid regurgitation.

“The hope is to provide a device that is able to capture the diseased tricuspid valve annulus, which has been enlarged inordinately by the ravages of functional tricuspid regurgitation, thus causing a reverse flow of venous blood from the right heart that should go to the lungs,”

Cleveland Clinic interventional cardiologist Samir Kapadia said: “This patient’s annulus measured 49.7 millimeters in diameter, and there are currently no valved stents that can secure such a dimension without extending into any of the chambers and still provide valvular function, yet there are millions of patients in the USA and worldwide presenting with this problem.”

Currently, the firm is carrying out clinical trials of it Navi mitral valved stent in Chile and Poland.

The stent will be used to correct functional mitral regurgitation (FMR), a similar condition affecting millions of patients across the globe.