Shanghai, China – Recently, VitaFlow LibertyTM Transcatheter Aortic Valve and Delivery System and Alwide® Plus Balloon Catheter, both developed by MicroPort CardioFlow Medtech Co., Ltd. ("MicroPort CardioFlow"), have received marketing approval from the Vietnam Ministry of Health (Registration Nos.: 2601164ĐKLH/HTTB-ĐKKD, 2601128ĐKLH/HTTB-ĐKKD). Both products are classified as Class D medical devices, the highest risk level in Vietnam, bringing superior treatment options to local patients with aortic valve disease.
The Vietnamese medical device market has strong demand for high-end imported products, and its regulatory system continues to align with international standards. Particularly for Class D high-risk medical devices, Vietnam implements stringent registration reviews, making product market access a significant regional benchmark. The simultaneous approval of MicroPort CardioFlow's two core TAVI products fully demonstrates that their safety and efficacy have been highly recognized by Vietnamese regulatory authorities. This also lays a solid compliance and clinical foundation for MicroPort CardioFlow to deepen its presence in the Southeast Asian market, further enhancing the regional influence of high-end medical devices manufactured with Chinese intelligence.
In recent months, the globalization of MicroPort CardioFlow's TAVI business has achieved significant rapid growth:
• In September 2025, monthly overseas implants exceeded 100 cases for the first time.
• In November 2025, the company reached the important milestone of over 1,000 cumulative commercial implants overseas.
• In December 2025, the company entered Africa for the first time, achieving full market coverage across four continents: Europe, the Americas, Asia, and Africa, with cumulative overseas implants for the year increasing by nearly 350% year-over-year.
• In January 2026, the first implant was completed in Saudi Arabia, the largest core market in the Gulf region, achieving coverage of multiple high-end markets in the Middle East.
• In March 2026, cumulative clinical applications exceeded 500 cases across 10 European countries, with continuous improvement in market penetration and steady expansion of international influence.
• To date, MicroPort CardioFlow's TAVI products have entered nearly 40 countries and regions worldwide, covering more than 900 leading hospitals, and serving nearly 20,000 patients with aortic valve disease.
Looking ahead, MicroPort CardioFlow will continue to accelerate its global expansion, striving to build a world-leading integrated platform encompassing "Structural Heart Disease + Cardiac Rhythm Management + Heart Failure Management." 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 around the world.
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