NaviGate Cardiac Structures touted this week that its Gate catheter-guided tricuspid atrioventricular valved stent was implanted six weeks ago into a patient’s transplanted heart.
The patient’s transplanted heart was failing due to severe tricuspid valve insufficiency. The successful implantation at the Policlinico of the University of Padua, Italy, is the first European-based patient treated with the company’s tricuspid replacement heart valve.
Three hours after the procedure, the patient was showing improved renal function, NaviGate reported. Two months after the intervention, the 67-year-old male patient has improved clinically and boasts excellent valvular function, according to the company.
This procedure brings the total number of NaviGate tricuspid implant cases that haven’t resulted in death after 30 days to three.
The patient received a heart transplant in 1990 for post-ischemic dilated cardiomyopathy, the company said, and had an array of comorbidities. Since the start of this year, he has reportedly had five hospitalizations for heart failure due to severe regurgitation of the tricuspid valve in his transplanted heart.
The patient was released five days after he received NaviGate’s replacement heart valve.
“This is the first size-52 mm Gate tricuspid AVS implanted, and the first tricuspid valve replacement in a failing transplanted heart in one of the leading cardiac centers in Europe. Our team is working diligently to reach the initiation of clinical trials in various centers in Europe from where we have received requests for our tricuspid replacement valve,” president & CEO Dr. Rodolfo Quijano said in prepared remarks.
The company’s implant is not cleared for investigational use in the U.S.