Clinical Experience

European Studies


Thubrikar Aortic Valve is currently enrolling patients in a first-in-human study of the Optimum TAVI System in Poland, which is a prospective, open-label, single-arm trial.

Successful 30-day outcomes announced on August 2, 2022.

Global First-in-Human Experience


01.

Successfully completed the First-in-Human implant of the Optimum TAV in a patient with severe aortic stenosis in December 2018, officially launching the Labcor Laboratórios clinical trial of the Optimum TAVI System in Brazil.

02.

The Optimum TAV was implanted percutaneously through the femoral artery using the Optimum TAVI delivery system. The patient experienced no complications in the procedure, and the valve functioned well with favorable hemodynamic performance and no paravalvular leakage.

03.

Clinical efficacy and successful valve hemodynamic performance have now been demonstrated at over 3 years. The patient continues to experience no symptoms.