Developing New Frontiers for Interventional Treatment of Structural Heart Diseases in China
Hangzhou Valgen Medtech Co., Ltd. ( Valgen Medtech) is dedicated to the interventional treatment of structural heart diseases. Founded in 2015 in Hangzhou, Valgen Medtech applied for more than 500 patents worldwide by the end of 2023. More than 150 patents were granted. Three independently-developed products passed the "Special Review of Innovative Medical Devices". Multiple interventional therapy devices, including the Dragon series, will greatly enrich clinical options in structural heart disease treatment.
The DragonFly™ Transcatheter Mitral Valve Repair System, as the first transfemoral vein edge-to-edge repair product developed in-house in China, passed its review in accordance with the Special Review Procedure for Innovative Medical Devices in March 2021. The product was granted marketing approval in China by the NMPA on November 29, 2023. The development of the product was supported by the National Key R&D Program for the "14th Five-Year Plan". In addition to the DragonFly™, Valgen Medtechs marketed products include the Pu Jie Jie™ Medical Radiation Protective Shield, Magpie™ Balloon Dilatation Catheter, DragonPath™ Transseptal Puncture System, Firework™ Stiff Guidewires, etc.
Valgen Medtech is headquartered in Hangzhou High-Tech Zone (Binjiang) Hangzhou and established an R&D center in Shenzhen. It has been accredited as a national and provincial (Zhejiang) technology-oriented SME, a high and new technology R&D center, and engineering research center in Hangzhou. Valgen adheres to the corporate strategy of being located in China and facing the world, further accelerating the development and clinical application of innovative treatment technology that addresses unmet clinical needs and continuously provides better solutions for patients around the world.
Source: China Blue TV
Development history
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2015
Hangzhou Valgen Medtech Co., Ltd., was founded
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Jul, 2020
The first successful in-human clinical application of DragonFly™ Transcatheter Mitral Valve Repair System
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Sep, 2020
DragonFly™ Transcatheter Mitral Valve Repair System successfully implanted in 10 patients in clinical
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Oct, 2020
DragonFly™ system, as an original Chinese medical device, made its debut in a 2020 CSI webinar
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Mar, 2021
Application for special review of Dragonfly™ Transcatheter Mitral Valve Repair System as an innovative medical device submitted and approved and special product review initiated
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Apr, 2021
Valgen Medtech topped the List of Chinese Unicorn Enterprises in 2020
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May, 2021
DragonFly™ Transcatheter Mitral Valve Repair System officially entered pre-marketing multi-center registration clinical study phase
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Jun, 2021
Valgen Medtech included as a cardiovascular intervention medical device manufacturer in the List of Most Innovative Medical Devices
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Jul, 2021
DragonFly™ made its debut in the 2021 CSI; its outstanding results in an early exploratory clinical trial made public to the world
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Aug - Sep, 2022
Valgen Medtech successfully passed four system audits by external notified bodies
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Nov, 2022
DragonFly™ earned support from the National Key Research and Development Program for the "14th Five-Year Plan"
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Nov, 2022
Pu JieJie™ radiation protection screen granted market approval
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Mar, 2023
Valgen Medtech showed up in live broadcast of the 2023 "NPC and CPPCC Sessions • Healthcare Strategies" series of interviews
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May, 2023
DragonFly™-DMR Trial follow-up results showed the predefined primary effectiveness and safety endpoints had been achieved
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Sep, 2023
DragonFly™ Transcatheter Mitral Valve Repair System won second prize in the final round of the High-value Medical Consumables Competition
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Nov, 2023
DragonFly™ Transcatheter Mitral Valve Repair System was officially granted marketing authorization by the NMPA
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