MicroPort CardioFlow Medtech (2160) Secures NMPA Green Path for TILEN/EYLEN ICD

Bulletin Express

Feb 13

MicroPort CardioFlow Medtech (2160) recently announced that TILEN/EYLEN, its new-generation implantable cardioverter defibrillator (ICD), has been proposed for approval into the National Medical Products Administration’s special review procedure for innovative medical devices. The device is expected to become the first domestically produced MRI-conditional ICD with proprietary intellectual property rights.

TILEN/EYLEN, part of the National Key R&D Program of the Ministry of Science and Technology, aims to address the domestic technical gap in ICD development. Its key features include Auto-MRI Function to simplify scanning and enhance patient comfort, Remote Follow-up capabilities leveraging Bluetooth® Low Energy technology, and a design intended to offer an extended product lifespan.

Data from multiple large-scale clinical trials shows ICDs are among the most effective measures for preventing sudden cardiac death, one of the leading causes of mortality worldwide. MicroPort CardioFlow Medtech’s PLATINIUM™ series ICD was approved in September 2024, making it the first domestically produced ICD of its kind. The new TILEN/EYLEN ICD’s entry into the NMPA Green Path is expected to advance the local development of high-energy defibrillation devices in China.

The company has noted that ultimate commercialization of TILEN/EYLEN cannot be guaranteed and advises caution in this regard.

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