Budapest and Pécs, Hungary - July 23-30, 2025 - The VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty^®), independently developed by MicroPort CardioFlow Medtech Corporation (02160.HK), has successfully completed its first 12 commercial clinical applications in Hungary.

Case 1

The inaugural procedures were performed by Prof. Béla Merkely and Dr. Levente Molnar from Semmelweis University Hospital, Prof. Péter Andréka and Dr. Géza Fontos from Gottsegen National Cardiovascular Center, as well as Dr. Kertész, Dr. Kracskó and Dr. Szokol from Debrecen University (Pécs) under the guidance of renowned expert Dr. Antoniadis. All patients showed no significant paravalvular leakage or other complications, demonstrating excellent clinical performance of the product.

The patient was a 73-year-old male. CT analysis revealed a stenotic tricuspid aortic valve with severely calcified and thickened leaflets. Measurements showed an annular perimeter of 73.9mm (mean diameter: 23.5mm), LVOT perimeter of 70.9mm (mean diameter: 22.2mm), sinus widths of 29.5mm/33.2mm/32.3mm, mean STJ diameter of 27.5mm, ascending aorta mean diameter of 29.3mm, and annular angulation of 50°.

This was a typical tricuspid valve case. Based on annular perimeter, the TAV 24 valve from VitaFlow Liberty^® series was selected. Due to severe leaflet calcification and thickening, a 22mm balloon was used for pre-dilation, with initial deployment planned at about 2mm below the leaflet. Given the heavy calcification, post-dilation with a 22mm balloon was performed after deployment. The right access route was chosen as the primary approach.

Final results showed 0mmHg transvalvular gradient, no significant paravalvular leakage, 6mm subvalvular implantation depth, good bilateral coronary flow, and no other complications.

Case 2

The patient was a 76-year-old female. Without preoperative CT reports available, the team decided to implant a TAV 27 valve after reviewing imaging and discussion, with 22mm balloon pre-dilation.

This typical tricuspid valve case received a TAV 27 valve from VitaFlow Liberty^®. The LVOT appeared cylindrical with mildly calcified and thickened leaflets. Apart from the annulus, other planes showed insufficient anchoring force, requiring 22mm balloon pre-dilation. Initial deployment was planned about 2mm below the leaflet.

After stent implantation, 22mm balloon post-dilation was performed. Final results showed 1mmHg transvalvular gradient, no significant paravalvular leakage, 5mm subvalvular implantation depth, good bilateral coronary flow, and no other complications.

Case 3

The patient was a 70-year-old male with severe aortic stenosis by echocardiography. CT showed a tricuspid aortic valve with severe calcification extending into the outflow tract. Measurements included annular perimeter of 83.5mm (mean diameter: 26.6mm), LVOT perimeter of 84.9mm (mean diameter: 27mm), sinus widths of 34.6mm/35.8mm/36.3mm, mean STJ diameter of 30.9mm, ascending aorta mean diameter of 37.3mm, and annular angulation of 51°.

This typical tricuspid valve case received a TAV 30 valve based on annular perimeter. Due to heavy calcification extending into the outflow tract, the team opted for 20mm balloon pre-dilation to reduce annular injury risk. The right access route was suitable and selected as primary approach.

Final results showed 5mmHg pressure gradient, no significant paravalvular leakage, 3mm subvalvular implantation depth, and no other complications.

The surgical team highly commended VitaFlow Liberty^®'s clinical performance. One operator noted:

"The innovative electric retrievable design significantly improves deployment stability, offering simpler operation than traditional manual systems while demonstrating excellent anti-migration capability for precise positioning."

"The delivery system's exceptionally soft tip provides outstanding deliverability - even in complex cases like Case 3 with severe aortic arch calcification, the valve passed smoothly without complications. Even with calcification extending into the outflow tract, the valve's strong radial force and unique double-layer skirt design effectively expand calcified tissue while significantly reducing paravalvular leakage."

As the world's first commercially available electric retrievable TAVI system, VitaFlow Liberty^® has accelerated its overseas commercialization since becoming the first China-made TAVI system to obtain EU CE MDR certification in 2024. With over 150 procedures completed in CE-marked countries, its implant in Hungary represents another successfully entered high-growth European medical device market. As European market expansion continues, this innovation is expected to further accelerate global adoption, bringing Chinese medical solutions to a broader international patient population.