Iasi, Romania — On February 4, 2026, the VitaFlow Liberty™ Transcatheter Aortic Valve and Retrievable Delivery System ("VitaFlow Liberty™"), independently developed by MicroPort CardioFlow Medtech Corporation (02160.HK, "MicroPort CardioFlow"), successfully completed its first commercial implants in Romania at the Iasi Institute of Cardiovascular Disease. To date, the product has been commercialized in over 10 European countries, with its commercial footprint spanning nearly 40 countries and regions worldwide.
The procedures were successfully performed at the renowned Iasi Institute of Cardiovascular Disease in Romania, with the distinguished Greek expert Dr. Dimitrios ANTONIADIS serving as the mentoring proctor, and the cardiac team led by Prof. Dr. TINICA GRIGORE and Dr. IGOR NEDELCIUC from the institute serving as the primary operators. The three patients presented with diverse anatomical characteristics, encompassing complex scenarios including moderately calcified trileaflet valves, high left coronary artery risk, and suspected bicuspid valve morphology. Postoperative evaluations demonstrated excellent valve function in all three patients, with no significant paravalvular leakage, coronary obstruction, conduction disturbances, or other complications, marking a complete success for all procedures.
Case Sharing
Case 1
01 Preoperative Assessment
The patient was an 80-year-old male with a trileaflet valve and moderate-to-severe calcification. CT analysis revealed an annulus circumference of 68.7mm (mean diameter: 21.9mm), LVOT circumference of 70.7mm (mean diameter: 25.5mm), sinus widths of 30.3mm/29.9mm/30.9mm, sinotubular junction (STJ) mean diameter of 27.5mm, ascending aorta mean diameter of 40.5mm, and an annulus angle of 51°.
CT Analysis
Coronary Risk Assessment
Left coronary height was favorable, right coronary height was favorable, indicating low risk of coronary obstruction.
Arch and Access Assessment
Right femoral artery minimum lumen diameter was 7.9 mm, recommended as primary access; femoral artery tortuosity was observed, suggesting the use of an extra-stiff guidewire to enhance support.
Summary and Procedural Strategy
This case presented typical trileaflet valve anatomy with low coronary risk. Based on the annulus circumference, a VitaFlow™ series TAV 24 valve was recommended, with pre-dilation using a 20 mm Alwide Plus™ balloon. During the procedure, the smooth and controllable characteristics of the VitaFlow Liberty™ were utilized, combined with an extra-stiff guidewire for enhanced support, to overcome the challenge of access tortuosity.
02 Procedure and Outcome
The valve was successfully deployed in a single attempt at the standard depth (2mm below the annulus). Immediate post-procedure transvalvular pressure gradient was significantly reduced to only 6mmHg. Echocardiography revealed mild paravalvular leakage, which was subsequently improved to trace paravalvular leakage following post-dilation with a 22mm balloon. No conduction disturbances or other complications were observed.
Case 2
01 Preoperative Assessment
The patient was a 70-year-old female with a trileaflet valve and moderate calcification. CT analysis revealed an annulus circumference of 69.7 mm (mean diameter: 22.2 mm), LVOT circumference of 71.0 mm (mean diameter: 22.6 mm), STJ mean diameter of 24.1 mm, ascending aorta mean diameter of 28.5 mm, and an annulus angle of 40°.
CT Analysis
Coronary Risk Assessment
High risk for the left coronary artery—leaflet length approached the coronary ostium with a small STJ; right coronary risk was low, but sinus width was relatively small.
Arch and Access Assessment
Right femoral artery minimum lumen diameter was 6.3 mm, approaching the lower limit of the product's access requirement (6.0 mm), and was recommended as primary access; pre-dilation of the vessel using an 18Fr sheath was advised.
Summary and Procedural Strategy
The core challenges in this case were high left coronary artery risk and a relatively small STJ. The team decided on a strategic deep implantation (positioning the valve 3-4mm below the annulus) and planned pre-dilation with a 20 mm balloon to assess coronary perfusion. Based on the annulus dimensions, a VitaFlow™ series TAV 24 valve was selected, leveraging the VitaFlow Liberty™'s precise positioning and smooth deployment capabilities.
02 Procedure and Outcome
The valve was deployed with precise positioning, and left coronary artery flow remained unobstructed. Immediate post-procedure assessment showed no paravalvular leakage, with a transvalvular pressure gradient of only 4mmHg, indicating significantly improved hemodynamics.
Case 3
01 Preoperative Assessment
The patient was an 83-year-old female with a Type 1 bicuspid valve (left-right fusion raphe) and mild calcification. CT analysis revealed an annulus circumference of 69.2 mm (mean diameter: 22.0 mm), LVOT circumference of 66.3 mm (mean diameter: 21.1 mm), STJ mean diameter of 28.3 mm, ascending aorta mean diameter of 32.5 mm, and an annulus angle of 58°.
CT Analysis
Coronary Risk Assessment
Risk for both coronary arteries was low.
Arch and Access Assessment
Right femoral artery minimum lumen diameter was 7.5 mm, recommended as primary access; abdominal aortic tortuosity was observed, suggesting the use of a stiff guidewire.
Summary and Procedural Strategy
This case involved bicuspid valve morphology (Type I, L-R fusion) combined with a small horizontal heart, making it the most anatomically challenging case in this series. Bicuspid anatomy imposes higher demands on valve anchoring, coaxiality, and deployment precision. Based on the annulus circumference, a VitaFlow™ series TAV 24 valve was selected. The operators fully utilized the cylindrical stent design of the VitaFlow™ series and the motorized retrievability advantage of the VitaFlow Liberty™ to ensure stable valve anchoring despite the asymmetric root structure.
02 Procedure and Outcome
The valve was deployed in an ideal position, with no significant paravalvular leakage, minimal pressure gradient, and no conduction disturbances or other complications. The product demonstrated excellent adaptability and stability even in this challenging bicuspid case.
03 Expert Evaluation
Mentoring Expert Dr. Dimitrios ANTONIADIS commented:
"The three cases in this first Romanian implant series were each representative of different challenges, particularly the high left coronary risk and bicuspid cases, which imposed extremely high demands on the TAVI system's deployment stability, positioning accuracy, and retrievability. The smooth, controllable deployment experience provided by the VitaFlow Liberty™, along with its enhanced radial support, offered distinct advantages, especially in the bicuspid case. This marks another successful showcase of MicroPort CardioFlow's TAVI technology in Central and Eastern Europe."
Primary Operator Prof. Dr. TINICA GRIGORE remarked:
"This was our center's first experience using the VitaFlow Liberty™. We were deeply impressed by its smooth arch crossing, deployment stability, and the immediate post-procedural outcomes. The team felt confident in the system's control, particularly when facing the high-risk left coronary and bicuspid cases. We thank Dr. Dimitrios for sharing his insights and techniques for using the VitaFlow Liberty™, and we look forward to deeper academic collaboration with MicroPort CardioFlow in the future."
04 Conclusion
Situated at the crossroads of Central-Eastern Europe and the Balkans, Romania, with its well-established healthcare system, has become an important regional medical hub in the Eastern EU. This first commercial clinical application not only represents another successful instance of medical technology cooperation between China and Romania but also signifies a further enhancement of the product's brand recognition in mainstream European markets.
Moving forward, MicroPort CardioFlow will continue to deepen its focus in the structural heart disease field, persistently improve its presence in the cardiac rhythm management sector, and strive to build a world-leading integrated platform encompassing structural heart disease, cardiac rhythm management, and heart failure management. Leveraging outstanding product performance, robust clinical evidence, and extensive international academic collaborations, the company is dedicated to providing innovative, comprehensive device solutions covering the full etiology, full stage, and full process of heart failure care for patients in Europe and around the world.
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