China, Shanghai – Recently, the second-generation TAVI product VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (“VitaFlow Liberty^®”), independently developed by MicroPort CardioFlow Medtech Corporation (02160.HK, “CardioFlow”), has received market approval (Licence No.: 81667100074) from the Brazilian National Health Surveillance Agency (ANVISA). The Alwide^® Plus Balloon Catheter, designed for use with this product, had previously obtained market access in Brazil.

VitaFlow Liberty^® is the world’s first electric retrievable TAVI product, approved for market launch in 2021 by China’s National Medical Products Administration (NMPA) (Registration Certificate No.: Guo Xie Zhun 20213030586). Since then, it has entered multiple overseas markets and, in 2024, became the first “Made-in-China” TAVI system to receive EU CE MDR certification. Building on the strengths of the VitaFlow^® Transcatheter Aortic Valve and Delivery System, it features a hybrid-density self-expanding stent, bovine pericardial leaflets, and a double-layer PET skirt design, delivering high radial strength, enhanced coaxial deployment, and reduced paravalvular leakage. Additionally, its breakthrough upgraded delivery system incorporates an innovative dual-helix structure, ensuring rapid, stable, and precise deployment/retrieval while enabling 360° bending flexibility for improved trackability.

Leveraging outstanding product innovation and strong clinical validation, CardioFlow has made steady progress in its global expansion strategy, with its market presence continuously growing. To date, its VitaFlow^® TAVI series and Alwide^® balloon accessory products have entered over 700 leading hospitals across 20+ countries and regions, treating more than 10,000 aortic valve disease patients worldwide.

As a core BRICS member, Brazil is not only the largest economy in Latin America (ranking among the top globally) but also the most populous country in the region, boasting a vast healthcare market. In the field of structural heart disease treatment, Brazil’s TAVI market is experiencing rapid growth, with an estimated 3,500–4,000 procedures projected for 2025. The approval of VitaFlow Liberty^® in Brazil marks a major breakthrough for China’s high-end medical devices in Latin America, challenging the duopoly of two U.S. giants that currently dominate ~90% of the market share. Moreover, it serves as a strategic foothold for CardioFlow to tap into high-potential overseas markets, providing strong momentum for its accelerated global strategy.

Lisbon, Portugal – May 14, 2025. The VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (hereinafter referred to as "VitaFlow Liberty^®"), independently developed by MicroPort CardioFlow Medtech Corporation (CardioFlow, 02160.HK), has successfully completed its first commercial implant at Hospital De Santa Cruz, a leading comprehensive hospital in Portugal. The procedure was performed by an expert team led by internationally recognized KOL Dr. Rui Teles. The patient showed no significant paravalvular leakage or other complications post-surgery, marking a great successful case.

Since becoming the first China-made TAVI system to obtain EU CE certification in 2024, VitaFlow Liberty^® has accelerated its commercialization across Europe. Portugal is the eighth high-growth European medical device market where the system has been successfully introduced, following Switzerland, Italy, Denmark, Spain, Serbia, Poland, and Greece.

Case details

Preoperative Assessment

The patient was a 63-year-old female. CT analysis revealed a tricuspid aortic valve with stenosis, mild calcification, an annular circumference of 67.8 mm, and a mean diameter of 21.6 mm. The left ventricular outflow tract (LVOT) circumference of 65.5 mm and a mean diameter of 20.9 mm. The sinus of valsalva were 26.8 mm, 25.9 mm, and 26.8 mm, respectively, with a mean diameter of 23.7 mm at the sinotubular juction (STJ) and 31.8 mm at the ascending aorta. The annular angle was 65°.

Case Strategy

This was a typical tricuspid valve case with mild calcification. Based on the annular perimeter, the TAV 24 valve from the VitaFlow Liberty^® was recommendation. Due to the patient’s mild calcification, the physician determined that the strong radial force of the VitaFlow stent could effectively expand the stenosis area, and thus decided to proceed with direct implantation without pre-dilation. The right femoral was recommended to be primary access.

Case Outcome

The final result showed a 3mmHg pressure gradient, no significant paravalvular leakage, a subvalvular implantation depth of 3mm, and no other complications.

Postoperative Evaluation

Following the procedure, Dr. Rui Teles praised VitaFlow Liberty^®, stating that its design meets international leading standards for TAVI systems. He highlighted its innovative double-layer skirt design, which effectively reduces paravalvular leakage, and its motorized delivery system, which ensures precise and stable valve deployment. He expressed optimism that the product would provide local patients with superior treatment options.

Conclusion

In Europe—a benchmark market for global medical device regulation, VitaFlow Liberty^® has not only overcome entry barriers but also gained widespread recognition from experts across multiple countries, demonstrating the global competitiveness of China’s high-end medical devices. Leveraging Europe’s thriving medical device market, valued at over €100 billion and ranking as the world’s second-largest, CardioFlow is accelerating VitaFlow Liberty^®’s overseas commercialization to expand market share and drive corporate growth. Simultaneously, the company continues to enhance product competitiveness through technological innovation and pipeline expansion, ensuring that China’s advanced medical solutions benefit more global patients with structural heart disease.
 

Shanghai, China, 25 March 2025 — Recently, 4C Medical Technologies, Inc. (4C Medical), a strategic partner of MicroPort^® CardioFlow, announced the closing of its Series D financing round, resulting in gross proceeds of up to $175 million, led by Boston Scientific Corporation, with participation from both new and existing shareholders. The financing will be utilized to accelerate the clinical development and commercialization of the AltaValve™ System, the company's next generation transcatheter mitral valve replacement (TMVR) technology.

4C Medical is a medical device company dedicated to advancing minimally invasive therapies for structural heart disease, particularly in the areas of mitral and tricuspid valve regurgitation. Previously, MicroPort^® CardioFlow made several rounds of investments in 4C Medical and holds exclusive commercial rights for AltaValve™ System in Mainland China, Hong Kong, Macau, and Taiwan. 

Mitral regurgitation (MR) is the most common valvular heart disease, and if untreated,  can lead to heart failure, arrhythmias, and even death. Current treatments include drug management, open surgical repair or replacement, and transcatheter edge-to-edge repair (TEER). However, for patients at high surgical risk, with severe mitral annular calcification, or complex heart anatomy, traditional treatments may not provide an effective or long-term solution.

The AltaValve™ System is the only fully retrievable transcatheter mitral valve system with a low outer diameter that passes through the atrial septum. Once launched, it is expected to be the first MR treatment that requires only atrial fixation. The innovative design overcomes the anchoring challenges of current TMVR technologies, protects the patient’s heart structure during the procedure, minimizes the risk of left ventricular outflow tract obstruction or injury, and improves clinical outcomes.

4C Medical is currently conducting a global pivotal trial ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) in the U.S. and Europe. The ATLAS pivotal trial is designed to assess the safety and effectiveness of the AltaValve™ System in treating patients with moderate-to-severe or severe MR who are unsuitable for surgery or TEER.The trial includes two separate non-randomized cohorts: moderate/severe mitral annular calcification (MAC) cohort and primary cohort that will include patients with no or mild MAC. The success of this trial is crucial for AltaValve™ System’s approval and market launch and will influence the broader field of TMVR technology. 

Guoming Chen, Chairman of MicroPort^® CardioFlow, stated, "As the largest shareholder before this round, we have witnessed 4C Medical’s growth from a concept to a leader in the global cardiovascular market. This financing is an important milestone, not only bringing hope to global MR patients but also validating MicroPort® CardioFlow’s long-term investment strategy in 4C Medical — supporting disruptive innovative enterprises and driving continuous advancements in structural heart disease treatments. With the growing demand for safe, effective, and minimally invasive treatments, TMVR is set to become a major treatment option. 4C Medical is well-positioned to lead in this field, and we will continue to support its growth, helping to improve patient lives worldwide."