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Third tricuspid valve stent implanted successfully in Italy

by Lisa Chamoff, Contributing Reporter | September 22, 2017
Cardiology Stents
A valved stent designed specifically for diseases of the right side of the heart that is awaiting regulatory clearance was recently implanted in a patient in Italy.

This is the third time, and the first time in Europe, that the GATE tricuspid Atrioventricular Valved Stent (AVS), developed by Lake Forest, Calif.-based NaviGate Cardiac Structures Inc. (NCSI), has been used successfully, without 30-day mortality, in cases for which there is no approved minimally-invasive treatment,

The 52-millimeter stent, the largest tricuspid valved stent available, was implanted through the jugular vein of a 67-year-old patient at the Policlinico of the University of Padua whose transplanted heart was failing due to severe tricuspid valve insufficiency. Two months after the procedure, the patient continued to improve and had excellent valvular function, according to the company.

The stent had previously been implanted via a catheter-guided technique in a patient at Cleveland Clinic under expanded access, or the use of a medical device or drug that has not been approved by the U.S. Food and Drug Administration.

The Italian facility had heard about the expanded access case in Cleveland and reached out to the company, said Dr. Rodolfo Quijano, the founder and chief executive officer of NCSI. While the heart’s left chamber can be treated with a minimally-invasive technique, there is no similar treatment for the tricuspid valve that is FDA approved.

“A lot of the cardiologists and surgeons are looking for something for their patients,” Quijano told HCB News.

The Italian Ministry of Health allowed the implant as a last resort for the patient.

The valve “is easy to use and took less than 10 minutes to place once we entered the right atrium,” said Giuseppe Tarantini, chief of interventional cardiology at the University of Padua, who performed the implantation, in a statement. “This will be helpful to many patients with advanced tricuspid insufficiency."

NCSI is training physicians in New York City, Milan and Frankfurt and there are five potential patients in Poland approved for the valve by that country’s minister of health, Quijano said.

In the meantime, clinical trials in Poland and Chile for the company’s NAVI mitral valved stent were amended to include the GATE tricuspid AVS.

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