Shanghai, China — MicroPort CardioFlow Medtech Corporation (02160.HK, "CardioFlow") recently announced that its VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System ("VitaFlow Liberty^®") and Alwide^® Plus Valvuloplasty Balloon Catheter ("Alwide^® Plus") have received registration approval from the Ministry of Healthcare of the Republic of Kazakhstan (Registration No.: ҚР-МБ (ММБ)-0№029027/ҚР-МБ (ММБ)-0№028972).

VitaFlow Liberty^®, the world’s first electric-retrievable TAVI (Transcatheter Aortic Valve Implantation) product, was approved by China’s National Medical Products Administration (NMPA) in 2021 and has since entered multiple overseas markets. In 2024, it became the first China-made TAVI system to obtain EU CE MDR certification. Building on the strengths of the VitaFlow^® system, it features a hybrid-density self-expanding nitinol stent, bovine pericardial leaflets, and a double-layer PET skirt, delivering high radial force, superior coaxial deployment, and reduced paravalvular leakage (PVL). Its breakthrough dual-helix retrieval mechanism ensures precise, stable deployment and retrieval, while enabling 360° flexural maneuverability.

Alwide^® Plus, a companion product for TAVI procedures, received NMPA approval in 2021 and is currently progressing toward EU CE MDR certification. Its ultra-low compliance enables precise balloon expansion while minimizing vascular injury. The high burst pressure effectively treats severely calcified lesions—a critical feature for Chinese patients. Additionally, its rapid inflation/deflation reduces pacing time and procedural risks, while enhanced puncture resistance improves intraoperative safety.

With proven clinical performance, CardioFlow’s global expansion has achieved remarkable success. To date, its VitaFlow^® TAVI series and Alwide^® balloon products have been adopted in 700+ leading hospitals across 20+ countries/regions, treating over 10,000 aortic valve disease patients worldwide.

Kazakhstan, the largest and most economically advanced country in Central Asia, is experiencing robust growth in its medical device market due to healthcare reforms and infrastructure upgrades. The approval of VitaFlow Liberty^® and Alwide^® Plus marks a strategic milestone in CardioFlow’s Asia-Pacific expansion, further solidifying its global footprint to benefit more structural heart disease patients.

Shanghai, China, 03 March 2025 – MicroPort^® CardioAdvent, a subsidiary of MicroPort^® CardioFlow, has received EU Medical Device Regulation (MDR) certification for its AnchorMan^® Left Atrial Appendage Closure System (AnchorMan^® LAAC system), securing market approval in just 14 months from registration (Registration Number: MDR 795462) . Its companion device, the AnchorMan^® Left Atrial Appendage Access System, also received approval.

Compared to open and closed left atrial appendage occluders, the AnchorMan^® LAAC system integrates the advantages of both. Its semi-closed structure, featuring 12 “3D folding” units and an advanced frame design, addresses key challenges associated with deep sheath placement in conventional plug-in closure systems while ensuring stable anchoring. The device’s rounded, soft distal end minimizes trauma to LAA tissue, while its dense NiTi alloy frame design ensures tight conformity to the LAA anatomy, providing superior sealing performance. Additionally, its two deployment options - advancement and unsheathing - offer physicians more flexibility during procedures.

In May 2023, the results of the pre-market clinical study SAFE PROTECT – a prospective, multicenter, head-to-head randomized controlled trial - were unveiled for the first time at the European Congress of Percutaneous Cardiovascular Interventions (Euro-PCR). The study successfully reached its primary endpoint and secondary efficacy endpoints within one year, with results showing low incidences of stroke, systemic embolism, major bleeding, transient ischemic attack (TIA), device-related complications, and device-related thrombus (DRT) among patients. This notably high clinical success rate and low adverse events at one year are attributed to its innovative design.

The successful EU certification of both the AnchorMan^® LAAC system and its access device paves the way for MicroPort^® CardioFlow’s expansion into the European market, reinforcing its commitments to stroke prevention in patients with atrial fibrillation. 

Jeff Lindstrom, President of MicroPort^® CardioFlow, stated, “This certification is a major milestone in our global journey. We remain dedicated to driving innovation, overcoming technological barriers, and expanding our interventional therapy portfolio to provide more comprehensive solutions for patients worldwide.”

Guoming Chen, Chairman of MicroPort^® CardioFlow, commented, “Following the success of VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System, AnchorMan^® LAAC system and its access system represent our second major entry into the EU market. As these products gain traction across Europe, they will create strong synergies, further enhancing brand recognition and market share, and jointly elevating our international presence.”

Shanghai, China, 07 January 2025 — MicroPort^® CardioFlow recently announced that its VitaFlow Liberty^® Flex Transcatheter Aortic Valve Implantation System (“VitaFlow Liberty^® Flex”) has received market approval from the National Medical Products Administration (NMPA) of the People’s Republic of China (Approval No. 20243032595). As the third generation transcatheter aortic valve implantation (TAVI) product from MicroPort^® CardioFlow, VitaFlow Liberty^® Flex delivers advanced medical solutions for the treatment of structural heart diseases, further benefiting physicians and patients in China.

VitaFlow Liberty^® Flex is the world’s only coaxial steering, self-expanding TAVI delivery system, and the first retrievable motorized TAVI delivery system. It features the innovative X³ Flexis™ 3D steering function for smoother and safer navigation over the aortic arch and valve, ensuring better coaxial alignment results. A shorter steering segment, positioned closer to the stent, enhances adaptability to the patient’s aortic anatomy. The inner tube steering technology maintains precise coaxial alignment during valve deployment, ensuring more stable and precise implantation. The system also includes a commissural alignment feature that preserves coronary access and leaves room for future coronary intervention. The delivery system is made of composite flexible materials to provide smoother navigation and reduce vascular complications. Additionally, the smart limit switch design incorporates intelligent braking during deployment, with audible and visual alarms to improve safety and enhance physician confidence during the procedure.

Mr. Jeff Lindstrom, President of MicroPort^® CardioFlow, commented: "The VitaFlow Liberty^® Flex will further enhance procedural efficiency and safety while significantly reducing surgical complications. It empowers physicians with enhanced usability while delivering higher-quality care to patients."

Mr. Guoming Chen, Chairman of MicroPort^® CardioFlow, remarked: "With over 15 years of commitment to the TAVI field, our VitaFlow^® series TAVI product has treated more than 10,000 patients with aortic valve disease and earned high praise from international experts. The launch of VitaFlow Liberty^® Flex brings cutting-edge innovative technologies to address more complex procedural scenarios and achieve superior clinical outcomes."