Two “compassionate case” nonagenarian patients have benefitted from a catheter-guided tricuspid atrioventricular valved stent (AVS). Both enjoyed “exceptional results” from the GATE™ stent at six weeks follow up.
Background
About two million U.S. patients present each year with moderate-to-severe tricuspid regurgitation. Their condition typically renders them inoperable by standard cardiac surgery, and there is no commercially available, safe and effective device that can correct the valvular incompetence and its debilitating sequelae. A large number of companies are working on devices and methods that may in the near future be suitable to correct the condition and be distributed and marketed.
NaviGate Cardiac Structures Inc. (“NCSI”) tells us about two implantations of the GATE™ AVS which were performed at New York-Presbyterian/Columbia University Hospital in New York. Each patient was discharged from the hospital within a few days.
The GATE™ atrioventricular valved stent is not approved for use in the USA. Hence the patient implants described in this news release were performed under compassionate pleas sanctioned by US FDA.
The Columbia Cardiac Team were greatly appreciative of the opportunity to provide a viable treatment option for these compassionate cases, and are very satisfied with the results to date. In both cases, implantation of the GATE™ AVS resulted in correction of tricuspid regurgitation and restoration of normal valvular function.
Physician comments
Dr. Rebecca Hahn, Director of Interventional Echocardiography at the New York-Presbyterian/Columbia University Medical Center and Professor of Medicine at CUMC said, “The patients are quite happy with the new valve and have reported feeling much better.
“Our 30-day follow-up imaging studies showed the valve to be functioning well in both patients with no or mild residual tricuspid regurgitation. We must continue to learn all we can about this valve since it seems that it may provide one possible answer to TR correction. Consequently, there is a need for close collaboration with all who are and will be implanting the valve. NCSI is preparing to initiate a clinical trial to gather all possible safety and effectiveness information for the GATE™ valve.”
Company comments
“We at NCSI were pleasantly surprised at how quickly the correction of severe TR and the restoration of valvular function occurs with the implantation of the GATE™ atrioventricular valved stent,” said Dr. R. C. Quijano, CEO of NCSI.
“We also know,” as Dr. Vinnayak Bapat, the surgeon of the Columbia Cardiac Team said after completion of the procedures, “that there is much work to be done, but we have a good beginning.”
Source: NaviGate Cardiac Structures Inc.
