LAKE FOREST, Calif.--(BUSINESS WIRE)--NaviGate Cardiac Structures Inc. (“NCSI”) announced today “exceptional results” for implantation of its GATE™ catheter-guided tricuspid atrioventricular valved stent (AVS) at six-week follow-up in two nonagenarian patients presenting with severe tricuspid valve insufficiency. Implantations of the GATE™ AVS were performed at New York-Presbyterian/Columbia University Hospital in New York. Each patient was discharged from the hospital within a few days.
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.
“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.”
“The patients are quite happy with the new valve and have reported feeling much better,” said Dr. Rebecca Hahn, Director of Interventional Echocardiography at the New York-Presbyterian/Columbia University Medical Center and Professor of Medicine at CUMC. “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.”
More and more, providers of structural heart therapies are realizing that the magnitude of tricuspid valve regurgitation (TR) is a burgeoning disease that is reaching epidemic magnitude. Presently in the USA, yearly about two million patients present with moderate-to-severe tricuspid regurgitation, in conditions that render 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. Worldwide the picture is similar: the numbers are estimated at more than 10 million patients, in continuous suffering, and multiple yearly hospitalizations attempting to ameliorate their condition but not able to correct the cause of the disease: the need to restore tricuspid valvular function. This explains the large number of companies working on devices and methods that may in the near future be suitable to correct the condition and be distributed and marketed.
The first NCSI patient, a 93-year-old male with a long history of cardiac conditions, including coronary artery disease (CAD) requiring angioplasty some years back, paroxysmal atrial fibrillation, previous carotid endarterectomy, cerebrovascular disease, diabetes and renal disease, had also been diagnosed with severe tricuspid regurgitation (TR). Dr. Rebecca Hahn notified the U.S. FDA of the plea by the patient for correction of the condition. Following concurrence from FDA and the New York-Presbyterian/Columbia Hospital’s Institutional Review Board, which was received pre-procedurally for both cases reported here, Dr. Hahn and her cardiac team, including Dr. Susheel Kodali, interventional cardiologist, and cardiac surgeons Dr. Vinnayak Bapat and Dr. Isaac George, planned the procedure. A GATE™ atrioventricular valved stent was implanted successfully, immediately demonstrating nearly complete correction of TR and normal valvular function. Follow-up echocardiogram at 30 days showed no structural or functional changes of the GATE™ valve.
The second patient, whose AVS procedure was performed on the same day, involved a 90-year old female with a long history of cardiac disease, including CAD requiring CABG in 1992, persistent atrial fibrillation, an enlarged right ventricle, diabetes, chronic kidney disease stage-2 and severe tricuspid regurgitation. Dr. Hahn and her team planned the procedure with guidance from Dr. Martin Leon, whose expertise in catheter-guided interventions is well-known. This case was also very successful, resulting in a normally functioning tricuspid valved stent demonstrating no significant TR by both fluoroscopic and echocardiographic evaluation. Echocardiogram at six weeks revealed a very “beautifully functioning valve,” noted Dr. Hahn.
NaviGate Cardiac Structures Inc. (www.navigatecsi.com) is an early-stage company focused on the development of catheter-guided correction of atrioventricular valves (tricuspid and mitral) for correction of regurgitation. The NaviGate valve-based technology was initially licensed from the Cleveland Clinic and later modified by NaviGate Cardiac Structures Inc.
NOTE: The GATE™ atrioventricular valved stent is not approved for use in the USA. The patient implants described in this news release were performed under compassionate pleas sanctioned by US FDA.