LAKE FOREST, Calif.--(BUSINESS WIRE)--NaviGate Cardiac Structures Inc. (“NCSI”) announced today 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 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.
The patient, a 67-year-old male with a long history of cardiac conditions received a heart transplant in 1990 for post-ischemic dilated cardiomyopathy and had a host of comorbidities [hypertension, osteoporosis with vertebral fracture, radical prostate surgery due to cancer (2006) and upper and middle right lobectomy for bullous dysplasia (2009)]. Since the beginning of 2017 the patient has had five hospitalizations for heart failure due to severe regurgitation of the tricuspid valve of his transplanted heart. The patient was released home (five days after the procedure), the GATE™ showed a transvalvular gradient of 2 mmHg with a trivial perivalvular leak. Also notable was that at discharge the patient’s renal function had improved significantly and a dramatic reduction in diuretics was prescribed.
“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,” said Dr. Rodolfo Quijano, President and CEO of NCSI.
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CAUTION: NCSI’s technology is not approved for investigational use in the United States.