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MicroPort Reaches 50-Products Milestone in China’s NMPA Innovative Medical Device Special Review Program

Press Release
Micro Port Press Release

Shanghai, China — October 16, 2026 — MicroPort Scientific Corporation announced that it and its associated companies have reached a cumulative total of 50 products accepted into China’s National Medical Products Administration (NMPA) Innovative Medical Device Special Review Program, commonly referred to as the “Green Channel.” MicroPort has ranked first in China’s medical device industry by number of products entering the program for eleven consecutive years.1

The 50th product to enter the program is NuWismen®, a liquid embolic agent being developed by MicroPort NeuroScientific for the treatment of cerebrovascular malformations.

The NMPA Innovative Medical Device Special Review Program provides a dedicated regulatory review pathway for qualifying innovative medical devices meeting criteria related to technological innovation, intellectual property, product development and significant clinical application value. Qualifying products receive enhanced communication and guidance during the registration process. Inclusion in the program does not constitute marketing approval.

MicroPort’s 50 products span a broad range of therapeutic areas, including comprehensive cardiac care; aortic and peripheral vasculature; robotics, life support, and clinical AI; neuroscience and neural interfaces; orthopedic joint, spine and trauma; and urology, oncology, and gastroenterology.

Several MicroPort products that previously entered the program have since progressed to broader clinical use, international commercialisation and additional regulatory milestones. Selected examples include:

  • Toumai® Surgical Robotic System (MicroPort® MedBot™): Toumai® has achieved several telesurgery milestones, including being the first NMPA-approved remote surgery system and the first to receive EU CE MDR certification for telesurgical procedures. It also received U.S. FDA IDE authorisation for telesurgery-related clinical evaluation. Global commercial orders have surpassed 300 units.
  • Firesorb® Bioresorbable Scaffold (MicroPort® Coronary): designed to provide temporary vascular support before being resorbed over approximately three to four years. Five-year follow-up from the randomised FUTURE-II trial reported no definite or probable device thrombosis with Firesorb®.2
  • VitaFlow Liberty® Transcatheter Aortic Valve System (MicroPort CardioFlow): the world’s first electrically actuated retrievable transcatheter aortic valve system. The VitaFlow® TAVI portfolio is now commercialised in more than 40 countries and regions, with more than 20,000 cumulative implantations.
  • Hector® Thoracic Aortic Multi-Branch Stent Graft System (MicroPort® Endovastec™): designed to enable minimally invasive endovascular reconstruction of the aortic arch and its three supra-aortic branches. Hector® received U.S. FDA Breakthrough Device Designation in 2026.
  • Tubridge® Flow Diverter (MicroPort NeuroScientific): the first domestically developed flow diverter approved in China. Tubridge® is now used in more than 1,300 hospitals across multiple countries, with cumulative implantations exceeding 30,000.
  • Columbus® 3D Cardiac Electrophysiology Mapping System (MicroPort EP): designed to support three-dimensional cardiac electrophysiology mapping during procedures. More than 100,000 procedures globally have been performed using the system.

Separately, two MicroPort-developed products - Hector® Multi-Branch Thoracic Stent Graft System and APOLLO Dream® Sirolimus Target Eluting Stent System - have received U.S. FDA Breakthrough Device Designation, supporting their continued global clinical and regulatory development.

“Medical innovation takes shape when a clinical need meets inventive engineering and teams with the discipline to make it a reality,” said Dr. Brian Chang, Chief Medical Officer of MicroPort Scientific Corporation. “Reaching 50 products in the NMPA Innovative Medical Device Special Review Program reflects MicroPort’s unique ability to bring these strengths together. This milestone is a testament to teams across MicroPort who reimagine how medical challenges can be solved and do the demanding work of turning new ideas into practical solutions for patients around the world.”

MicroPort will continue to focus on medical technology innovation addressing important clinical needs, with the aim of expanding access to high-quality medical solutions for patients worldwide.

About MicroPort Scientific Corporation (MicroPort®)

Since 1998, MicroPort® (MicroPort Scientific Corporation; HKEX: 00853) has been breaking barriers and accelerating access to life-changing solutions so that patients everywhere can live better and longer lives. As a global medical device company, MicroPort® provides solutions across eight therapeutic areas, including comprehensive cardiac care; aortic and peripheral vasculature interventions; robotics, life support, and clinical AI; neuroscience; and orthopedics. Serving over 100 countries and 20,000 hospitals, MicroPort® provides a medical solution to a patient every 5 seconds.

Regulatory Status

Products and technologies referenced in this release are at different stages of development and commercialisation. Inclusion in the NMPA Innovative Medical Device Special Review Program, U.S. FDA Breakthrough Device Designation or FDA IDE authorisation does not constitute marketing approval. Regulatory status, approved indications and product availability vary by country or region.

Reference

  1. Data on file 
  2. Song L. Five-year outcomes of thinner-strut Firesorb bioresorbable scaffold in the FUTURE-II trial. Presented at EuroPCR 2026; May 19, 2026; Paris, France.

 

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