NaviGate Cardiac Structures Inc today touted that the first patient to receive its Gate tricuspid valved stent through a transjugular access procedure under compassionate use protocols has reached one year post-procedure and still maintains excellent valvular function.
The procedure was performed last April at the Cleveland Clinic, the Lake Forest, Calif.-based company said. At one year, the patients’ bioprosthesis is demonstrating “excellent leaflet mobility and valve function,” NaviGate said.
A total of 16 patients have been treated with the valve for severe tricuspid regurgitation, the company said, with most patients being treated at the Columbia Presbyterian Hospital. A total of four patients have been treated with the Gate valve at the Cleveland Clinic with no reported 30-day mortality.
“NCSI is working diligently to move into a feasibility clinical trial to initiate Safety and Effectiveness research of the tricuspid bioprosthesis. These compassionate plea patient implants are instructive and obviously are good for the patients who have no other recourse, although we find several who cannot be helped by the valve since their ventricular function is beyond repair and their postoperative course would be troubled. Careful patient selection is imperative to obtain proof of what the GATETM tricuspid valved stent bioprosthesis can or cannot do, and that requires a well-controlled clinical trial to obtain such evidence, which we hope to start later in the year. Until then, we have requests from many centers in Europe, the U.S. and Canada to do both: more compassionate cases and a full trial,” NCSI CEO Dr. R. Quijano said in a press release.
In February, NaviGate said that its catheter-guided Gate valved-stent bioprosthesis became the first orthotopic valve replacement in Canada to treat severe tricuspid regurgitation.