NaviGate Cardiac Structures, Inc. (“NCSI”) reports first heterotopic transcatheter GATE™ tricuspid valved stent successful implantation

LAKE FOREST, Calif., NaviGate Cardiac Structures Inc. (“NCSI”) announced today that the GATE™ catheter-guided tricuspid atrioventricular valved stent (AVS) was implanted through the jugular vein one week ago in a patient suffering from severe tricuspid regurgitation stemming from two failed tricuspid annuloplasty rings that were unable to maintain the patient’s valve competence.   

The patient, a 78-year-old man with a long history of cardiac conditions, has undergone four cardiac surgeries, including two coronary bypass surgeries and two failed valve repairs.  The patient had become symptomatic of right heart failure and opted to make a compassionate plea to his physician for the valved stent under development.  US FDA allowed the compassionate use. Dr. Jose Navia and Dr. Samir Kapadia proceeded  with the implantation.  After receiving the valve, the patient became stable. He has been closely watched by the cardiac team and was discharged to home.

Dr. Jose Navia, the staff surgeon and researcher who sponsored the use at Cleveland Clinic, said: “We were able to perform this procedure in its entirety percutaneously through the jugular vein in a beating heart. In addition, the tricuspid valve was implanted within the failed annuloplasty ring, providing another alternative in treating tricuspid disease.” Dr. Navia is a member of NaviGate’s scientific advisory board and a company shareholder. As the inventor of the technology, he is entitled to a portion of any commercialization revenues received by Cleveland Clinic. 

Dr. Samir Kapadia, Director of the Catheterization Laboratory, another member of the cardiac team at Cleveland Clinic, explained: “This was a patient who was very high-risk and would not have qualified for another conventional operation. Transcatheter valve implantation was performed in a hybrid room similar to other transcatheter valve replacements. The valve was implanted accurately and the patient has done well, and we will continue to monitor him throughout his recovery.” Dr. Kapadia is a member of NaviGate’s scientific advisory board and holds equity in NCSI.

Dr. Lars Svensson, chair of the Miller Family Heart & Vascular Institute at Cleveland Clinic, stated: “Tricuspid valve regurgitation affects some one million patients in the USA and the treatment for heart failure related to the regurgitation can be difficult. Jose Navia, MD, has had a long interest in the surgical treatment of the problem. Dr. Navia has now innovated an approach and for the first time has used a percutaneous approach through a neck vein to replace the valve. This is the type of pioneering that will make a difference in the treatment of this difficult condition.”

The GATE™ tricuspid AVS has been developed and manufactured by NCSI.  The company also has developed the percutaneous NAVI™ valve for mitral valve replacement as well as tissue-preservation techniques that remove the toxic tissue fixatives thought to affect the longevity of tissue[KM1] . This technology removes most of the  liquid so that the device can be shipped in the “dry” form. NCSI[KM2]  licensed the seminal technology from Cleveland Clinic.

NCSI made modifications to the device that differentiates it from all others presently manufactured for atrioventricular valves.  The unique design of this device in the form of a diffuser or truncated cone exhibits a low-height profile that can be more easily threaded through the vasculature to reach the atrioventricular valves, allowing it to reside without protrusion into either of the adjacent chambers (atrium or ventricle) for mitral or tricuspid valves, while simultaneously allowing the largest possible diameters to capture the enlarged annulus typical of the dysfunctional tricuspid valve resulting from Dilated Cardiomyopathy (DCM); thus, valves in sizes of up to 48 mm - 50 mm can be manufactured.

“We are so excited to see our device helping the patient so well,” stated Dr. Tino Quijano, CEO of NCSI. “Although we tried the implantation in 3D  reproductions[KM3]  of the patient’s right heart that included the non-circular annuloplasty ring and saw it work, when it is done in the patient it does bring to our heart a bit of anxiety, but we know that in the hands of the cardiac team, our device will correct the tricuspid incompetence and show safety and function[KM4] .  NCSI has obtained approvals in Chile and Poland to start implantations of the GATE™ AVS and patients are being screened.  Its uniqueness has gained the attention of various cardiac centers in the Americas and Europe and as far as New Zealand, which are requesting it for so many patients for which now they hope to have a functioning alternative.”

The worldwide patient population for these two conditions in their severe stage is in the millions yearly,[KM5]  which explains the extensive effort being made by many large multinational medical companies as well as the plurality of start-up venture companies that have focused for the last decade on mitral replacement and repair and those that are now pursuing the repair and replacement of the “forgotten” tricuspid valve.