Experimental transcatheter tricuspid stent implanted into patient at Cleveland Clinic

A new transcatheter tricuspid valved stent was successfully implanted into a patient at the Cleveland Clinic to treat tricuspid regurgitation, a disease grossing billions of dollars in treatments annually.

The stent, made by NaviGate Cardiac Structures, an early-stage company that develops transcatheter solutions in Lake Forest, California, was placed in a 64-year-old woman who has a history with the disease, putting her at a higher risk for heart failure, according to a statement from NaviGate. The patient’s heart annulus measured 49.7 millimeters in diameter, a length that no other stents could secure.

The NaviGate stent was implanted using a catheter-guided technique, and at 30 days, the patient was stable and recovering smoothly.

“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 Jose L. Navia, MD, a Cleveland Clinic cardiovascular surgeon and a member of NaviGate’s scientific advisory board and company shareholder.

The stent differs from others primarily because it is designed in the form of a diffuser that allows it to be easily threaded through the vasculature to reach atrioventricular valves.

“Our quest 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,” said Rodolfo Quijano, MD, president and CEO of NaviGate. “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.”

NaviGate is also currently conducting clinical trials in Chile and Poland to test its NVI mitral valved stent, designed to correct mitral regurgitation.