31 August 2017 - - Lake Forest, California-based NaviGate Cardiac Structures Inc. (NCSI) has reported that its GATE catheter-guided tricuspid atrioventricular valved stent (AVS) was implanted through the jugular vein six weeks ago into a patient's transplanted heart that was failing due to severe tricuspid valve insufficiency, the company said.
The successful implantation of the GATE AVS at the Policlinico of the University of Padua, Italy, represents the first European patient treated with the NCSI tricuspid replacement heart valve.
Three hours after the intervention the patient was awake and showing improved renal function. Now, approximately two months post-procedure, the patient continues to demonstrate clinical improvement and excellent valvular function.
This brings the total number of NCSI GATE tricuspid implants without 30-day mortality to three.
"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," said Dr. Rodolfo Quijano, president and CEO of NCSI.
NCSI is an early-stage company focused on developing transcatheter solutions for the treatment of atrioventricular valve regurgitation.
The NaviGate valved-based technology was licensed from Cleveland Clinic and further modified and developed by NCSI. The valves are offered in 3 sizes for each application to capture the range of dilated mitral valve annulus or tricuspid valve annulus.