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MicroPort® CardioFlow's VitaFlow Liberty® Obtains Marketing Approval in Turkey
2024-12-06
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Shanghai, China — MicroPort CardioFlow's second-generation transcatheter aortic valve implantation (TAVI) device, the VitaFlow Liberty® Transcatheter Aortic Valve and Retrievable Delivery System (referred to as "VitaFlow Liberty®"), has recently been granted market approval by the Turkish Medicines and Medical Devices Agency (TÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU). This product was developed independently by MicroPort CardioFlow Medical Technology Co., Ltd. (02160.HK, referred to as " MicroPort CardioFlow").

 

VitaFlow Liberty®, the first electrically retrievable TAVI system in the world, received market approval from China's National Medical Products Administration (NMPA) in 2021 (Registration Number: National Medical Device Approval 20213130655). Since then, it has successfully entered various international markets and became the first domestically developed TAVI system in China to achieve EU CE MDR certification this year. Currently, the VitaFlow® series of TAVI products, along with its Alwide® balloon accessories, have been implemented in over 700 leading hospitals across more than 20 countries and regions, treating over 10,000 patients with aortic valve diseases globally.

 

Turkey, a densely populated nation located at the crossroads of Asia and Europe and the 17th largest economy in the world, has experienced significant growth in its medical device market over the last decade. From 2010 to 2020, the market's average growth rate reached an impressive 17%, ranking third in Central and Eastern Europe and second in the Middle East and North Africa (MENA) region. As a key player in Turkey's medical device sector, the local TAVI market is projected to reach a capacity of 4,000 units by 2024, with over 95% of devices being imported, primarily from leading U.S. companies that hold more than half of the market share.

 

The recent approval of VitaFlow Liberty® in Turkey not only provides patients with structural heart diseases access to more high-quality treatment options but also signifies further international acknowledgment of China's innovative technological advancements. This achievement is expected to revitalize and create new opportunities for China's high-end medical devices in the global market.

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