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Thubrikar Aortic Valve Expands TAVI-1 CE Mark Trial with Precision 2™ Catheter Authorization

Saturday, December 16, 2023

Thubrikar Aortic Valve has obtained approval from the Competent Authority in Poland to extend the TAVI-1 CE Mark trial for the Optimum Transcatheter Aortic Valve Implantation System™ (Optimum TAVI System™). This clearance allows an additional 15 patients to undergo treatment with the Optimum TAV™ utilizing the Precision 2™ Catheter, the company's second-generation delivery catheter. The Precision 2 Catheter provides operators with enhanced control, enabling repositioning and recapturing of the Optimum TAV during the procedure if necessary.

The unique catheter design allows the Optimum TAV's short frame to reorient during deployment in the diseased valve, ensuring automatic axial alignment. The expanded approval also includes the addition of a clinical site in Poland, incorporating patient implants at both the Specialty Hospital Jana Pawla II in Krakow and the University Clinical Hospital Jana Mikulicza-Radeckiego in Wroclaw.

The Optimum TAV distinguishes itself with 1- and 5-year patient outcomes, highlighting its superior design and durability—particularly suitable for younger patients. With a height of less than half of commercial self-expanding platforms, the Optimum TAV provides full coronary access. It replicates the optimal geometry and leaflet dynamics of the natural aortic valve, standing out by having no suture holes in the flexion zone, representing a notable advancement in the evolution of TAVI procedures.


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