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. The study complies with new European regulations (EU MDR) and will be used towards obtaining regulatory approval in Europe (CE Mark).
Successful initial outcomes
Two patients with symptomatic severe Aortic Stenosis were successfully treated with the Optimum TAVI System in Krakow, Poland in April 2022. The TAVI procedures were conducted using a minimalist approach: general anesthesia and transesophageal echocardiogram were not used, and the Optimum TAV was implanted using percutaneous femoral artery access. In both patients, the Optimum TAV was delivered successfully without complications or obstruction of the coronary arteries. The patients were ambulating the next day and discharged soon thereafter.
The patients have shown remarkable clinical improvement. Post procedure, they were changed to New York Heart Association (NYHA) Class I, a measure of functional status and symptoms defined as “No symptoms and no limitation in ordinary physical activity,” and had increased Kansas City Cardiomyopathy Questionnaire (KCCQ-12) scores, a patient-reported measure of quality of life. The performance of the Optimum TAV has been outstanding, with post implant mean pressure gradients (a measure of aortic stenosis severity) and aortic valve effective orifice areas superior to most commercially available transcatheter aortic valves.
All primary outcome measures of the study were met. At 30 days, VARC-3 clinical endpoints of device success and early safety were achieved. The patients are free from all-cause mortality, stroke, major bleeding, pacemaker implantation, moderate to severe regurgitation, and vascular complications. The patients continue to experience no symptoms, and their quality of life has dramatically improved.
Global First-in-Human Experience
Excellent performance over 4 years
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.
The Optimum TAV was implanted using percutaneous femoral artery access with 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.
Clinical efficacy and excellent valve hemodynamic performance have now been demonstrated at over 4 years. The patient continues to experience no symptoms.