Thubrikar Aortic Valve is currently enrolling patients in a clinical trial of the Optimum TAVI System in Poland. This prospective, open-label, single-arm trial complies with European Medical Device Regulations (EU MDR) and is intended to obtain CE Mark approval. The trial is expected to broaden to additional sites across Europe.

To date, 12 patients with symptomatic, severe Aortic Stenosis have been successfully treated at the John Paul II Hospital in Krakow, Poland. The trial has now expanded to the University Clinical Hospital in Wroclaw, Poland, and will include a total of at least 20 patients.

All TAVI procedures have been performed using a minimalist approach: without general anesthesia or transesophageal echocardiography, and the Optimum TAV was implanted using percutaneous femoral artery access. All implants were completed successfully without complications or obstruction of the coronary arteries, and post-procedure recovery was rapid. Some patients presented anatomical challenges, however the outcomes remained positive.

Patients have demonstrated significant clinical improvement. Early symptom relief was reflected in improved New York Heart Association (NYHA) classifications, shifting from Class II/III to Class I/II. Quality of life scores, measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12), have markedly increased and remained elevated through 3-year follow-ups. All patients are free from all-cause mortality, stroke, and hospitalization.

Post-implant hemodynamic results remain strong across all patients, with mean pressure gradients (a measure of aortic stenosis severity) and aortic valve effective orifice areas consistently superior to those published for any transcatheter aortic valve of comparable size. No cases of moderate or severe regurgitation, major bleeding, or vascular complications have been reported.

These early outcomes are a testament to the superior design of the Optimum TAVI System and set a new standard in Transcatheter Aortic Valve Implantation.