MicroPort CardioFlow’s VitaFlow™ SELFValve™ Transcatheter Mitral Valve Replacement System Enters NMPA Innovative Medical Device Special Review Program

Shanghai, China — August 25, 2026 — MicroPort CardioFlow announced that its VitaFlow™ SELFValve™ Transcatheter Mitral Valve Replacement (TMVR) System has been accepted into China’s National Medical Products Administration (NMPA) Innovative Medical Device Special Review Program, commonly referred to as the “Green Channel.” This marks the sixth product from MicroPort CardioFlow to enter the special review program.

Mitral regurgitation is a common heart valve condition in which blood flows backward through an incompletely closed mitral valve during cardiac systole. As the disease progresses, patients may experience symptoms including dyspnea, fatigue, arrhythmia, and heart failure. For elderly and high-risk patients who cannot tolerate surgery, as well as patients who are anatomically unsuitable for transcatheter edge-to-edge repair (TEER), treatment options may remain limited.

Approximately 7.5 million patients with mitral regurgitation in China are estimated to require intervention.¹ TMVR provides an additional treatment pathway by implanting a prosthetic valve via a transcatheter approach to replace the diseased native mitral valve.

VitaFlow™ SELFValve™ is being developed for patients with symptomatic moderate-to-severe or severe degenerative mitral regurgitation who are assessed to be unable to tolerate surgery and are anatomically unsuitable for TEER. The system incorporates several design features intended to address the anatomical and procedural complexity of transcatheter mitral valve replacement:

· Anchoring and sealing: A dual-anchoring mechanism combined with a sealing skirt is designed to accommodate a range of annulus sizes and support stable anchoring and paravalvular sealing.

· Valve durability: A dry-valve anti-calcification technology replaces traditional glutaraldehyde liquid preservation and is designed to support biocompatibility and long-term valve performance.

· Hemodynamic performance: A large effective orifice area is designed to support blood flow and low transvalvular gradients.

· LVOT protection: A dedicated left ventricular outflow tract (LVOT) protection structure, combined with an infra-annular retractable stent and covered fenestrated design, is intended to address the risk of LVOT obstruction.

· Procedural control: A controlled-release and rapid-retrieval design is intended to support precise positioning and procedural control.

VitaFlow™ SELFValve™ completed its first-in-human implantation in 2022. Clinical evaluation has since expanded across multiple centers in China and France, with dozens of implantations completed to date.²

In addition to VitaFlow™ SELFValve™, MicroPort CardioFlow is advancing the global clinical development of the AltaValve™ TMVR system through its associate company, 4C Medical Technologies. The two technologies employ differentiated approaches to mitral valve replacement and form part of MicroPort CardioFlow’s broader mitral valve development pipeline.

Inclusion in the NMPA Innovative Medical Device Special Review Program provides VitaFlow™ SELFValve™ with access to a dedicated regulatory review pathway, including enhanced communication and guidance during the registration process. Inclusion in the program does not constitute marketing approval.

About MicroPort CardioFlow:

MicroPort CardioFlow Medtech Corporation (HKEX: 02160.HK, an associated company of MicroPort Scientific Corporation; HKEX: 00853) develops innovative technologies for structural heart disease and cardiac rhythm management. With roots in the development of therapies for structural heart disease, the company holds a leading position in China's TAVI market and has built one of the broadest portfolios in the segment.

CardioFlow now combines its structural heart business with MicroPort CRM’s more than 60 years of rhythm management expertise, including 12 core development programs and a global portfolio of over 40 marketed products across pacemakers and ICDs. Together these form an integrated platform spanning structural heart intervention and cardiac rhythm management with a unique synergy to address heart failure.

By providing physicians and patients with innovative, full-cycle cardiac health management, the company is dedicated to building a leading enterprise of emerging technologies in cardiac diagnosis and therapy. More information is available at: https://cf.microport.com/

Regulatory Disclaimer

The VitaFlow™ SELFValve™ Transcatheter Mitral Valve Replacement System has been accepted into the NMPA Innovative Medical Device Special Review Program in China. Inclusion in this program does not constitute marketing approval. VitaFlow™ SELFValve™ has not yet been approved for commercial use by the NMPA. Regulatory status and product availability may vary by country or region.

References

1. Pan W, Zhou D, Ge J. Estimation of the number of patients with mitral regurgitation in China. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery. 2021;28(5):495–498. doi:10.7507/1007-4848.202012080.

2. Data on file, MicroPort CardioFlow. VitaFlow™ SELFValve™ clinical experience; ongoing clinical evaluation.