News | Heart Valve Technology | January 29, 2019

Thubrikar Announces First-in-Human Implant of Optimum TAVI System

Procedure marks beginning of Brazilian clinical trial for transcatheter aortic valve implantation system

Thubrikar Announces First-in-Human Implant of Optimum TAVI System

January 29, 2019 — Thubrikar Aortic Valve Inc. announced the first human implant of the Optimum TAV using their transcatheter aortic valve implantation (TAVI) system.

The implant commences a clinical trial sponsored by the company’s Brazilian licensee, Labcor Laboratórios Ltda., who manufactured the implanted valve designed by Thubrikar.

Mathew Williams, M.D., director of the Heart Valve Center at NYU Langone Health, proctored the team of cardiac surgeons and interventional cardiologists, that included Gustavo Kikuta, M.D., Pedro Jazbik, M.D., and others, to do the implant at the Hospital Universitario Pedro Ernesto in Rio de Janeiro, Brazil.

The patient was a 79-year-old woman with severe aortic stenosis. The Optimum TAV valve was implanted percutaneously through the femoral artery. She experienced no complications and was discharged home and is doing very well. The Optimum TAV was functioning very well without any leak.

Dr. Ivan Casagrande, co-founder of Labcor said, “We are very pleased to initiate this clinical trial of the licensed technology from Thubrikar and anticipate completion of the trial in 2019.”

Joaquin Coutinho, M.D., head of cardiac surgery at Pedro Ernesto, said, “We are particularly excited to witness the success of the FIH of this important next-gen TAVI system, and we look forward to participating in Labcor’s clinical trial of these devices in Brazil.”

Labcor expects to complete the clinical trial this year.

For more information: www.tavi.us

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