NaviGate's Transcatheter Tricuspid Valved Stent Successfully Implanted in a Compassionate-Use Procedure

May 5, 2017—NaviGate Cardiac Structures Inc. (NCSI) recently announced the first successful implantation of the company's Gate catheter-guided tricuspid atrioventricular valved stent. The device was implanted through the jugular vein in a patient with severe tricuspid regurgitation stemming from two failed tricuspid annuloplasty rings that were unable to maintain the patient’s valve competence.

The procedure was performed by Jose Navia, MD, and Samir Kapadia, MD, at Cleveland Clinic in Cleveland, Ohio, under a compassionate-use approval from the US Food and Drug Administration. 

According to NCSI, the patient is a 78-year-old man with a long history of cardiac conditions, who has undergone four cardiac surgeries, including two coronary bypass surgeries and two failed valve repairs. The patient had become symptomatic for right heart failure and opted to make a compassionate plea to his physician for the valved stent under development. After receiving the device, the patient became stable. He has been closely watched by the cardiac team and was discharged to home.

NCSI is an early stage device development company, and its products are not available in the United States. The NaviGate valved-base technology was licensed from Cleveland Clinic and further modified and developed by the company.

Dr. Navia, who is the inventor of the Gate technology, is a staff surgeon in the Department of Thoracic and Cardiovascular Surgery in the Sydell and Arnold Miller Family Heart & Vascular Institute at Cleveland Clinic. He is a member of NCSI’s scientific advisory board and a company shareholder. Dr. Kapadia is Director of the Catheterization Laboratory at Cleveland Clinic. He is also a member of the company’s scientific advisory board and holds equity in NCSI.

In the company's announcement, Dr. Navia commented, “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. Kapadia added, “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.”

Lars Svensson, MD, who is Chair of the Miller Family Heart & Vascular Institute at Cleveland Clinic, stated, “Tricuspid valve regurgitation affects some 1 million patients in the United States and the treatment of heart failure related to the regurgitation can be difficult. Dr. Navia has had a long interest in the surgical treatment of the problem. He 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.”