LAKE FOREST, Calif.–(BUSINESS WIRE)–December 30, 2016–

NaviGate Cardiac Structures Inc. (“NCSI”) announced today that a novel valved stent that can capture the enlarged annulus in patients suffering from functional tricuspid regurgitation (FTR) was implanted in a patient presenting with massive incompetence of the tricuspid valve.

The patient, a 64-year-old female with an extensive history of severe tricuspid regurgitation (TR 4+) that invariably results in right heart failure (RHF), a lethal condition, was successfully treated with the GATE™ tricuspid Atrioventricular Valved Stent (AVS) from NCSI. The cardiac team from the Cleveland Clinic, recognized as the number-one cardiac medicine center in the USA for 22 consecutive years, implanted the AVS with catheter-guided technique under a compassionate plea from the patient. (A compassionate plea allows a special permission for medical procedures deemed to be the last resort for patients with conditions for which no approved device or medicine exists.)

After the implantation, the valve demonstrated excellent valvular function, indicating correction of the massive regurgitation problem. The patient became stable and was closely observed by the cardiac team and at 30 days post implantation is doing quite well.

“This is a step forward in the treatment of tricuspid regurgitation. The hope is to provide a device that is able to capture the diseased tricuspid valve annulus, which has been enlarged inordinately by the ravages of functional tricuspid regurgitation, thus causing a reverse flow of venous blood from the right heart that should go to the lungs,” said Cleveland Clinic cardiovascular surgeon Dr. Jose L. Navia, a member of NaviGate’s scientific advisory board and company shareholder.

“This patient’s annulus measured 49.7 millimeters in diameter, and there are currently no valved stents that can secure such a dimension without extending into any of the chambers and still provide valvular function, yet there are millions of patients in the USA and worldwide presenting with this problem,” said Dr. Samir Kapadia, Cleveland Clinic interventional cardiologist. Dr. Kapadia also serves as a scientific advisory board member to NaviGate.

The GATE™ tricuspid AVS has been developed and manufactured by NCSI, which licensed the seminal technology from Cleveland Clinic. The technology platform, initially explored at Cleveland Clinic, includes percutaneous valve devices for mitral valve replacement and tissue-preservation techniques that remove the toxic tissue fixatives, which-although allowing the fabrication of biological valve replacement from animal tissues leaves residuals that are thought to promote untoward effects for the longevity of tissue. The technology removes most of the water so that the device can be shipped in the “dry form.”

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.

“Our quest,” said Dr. R. Quijano, President and C.E.O. of NCSI, “is to fully develop and provide the medical community with systems of devices to replace the lost function of both atrioventricular valves of the heart, the tricuspid and the mitral, and to develop the easiest, most user-friendly and most secure methods for their use. Not an easy task, granted. These devices could be used by cardiologists delivered either by threading through the vasculature (so long as the patient has no blood clots in those vessels), or alternatively through minimally invasive surgical and beating-heart techniques by the surgeon when the former is not advisable.”

NCSI is presently conducting clinical trials (Chile and Poland) of its NAVI™ mitral valved stent for correction of Functional Mitral Regurgitation (FMR), a similar deadly condition affecting millions of patients worldwide. One patient in Chile has just passed the one-year mark and returned to work with a functional valve.

The healthcare market for these two conditions reaches close to $20 billion yearly, 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.

* New York Heart Association (NYHA) Functional Classification Scale for TR-4+: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Ronald Trahan Associates
Ronald Trahan, APR, +1-508-359-4005, x108