MP CARDIOFLOW-B(02160): Implantable cardiac resynchronization defibrillator entering Innovative Medical Management special review process.

MP CARDIOFLOW-B (02160) Announcement: The National Medical Products Administration (NMPA) Medical Device Technology Evaluation Center recently issued a notice on the results of the Special Review Application for Innovative Medical Management Devices (No.3 in 2026), proposing to approve the group's next-generation implantable cardioverter-defibrillator (ICD) TILEN/EYLEN to enter the Innovative Medical Management Device Special Review Program (NMPA Green Channel). As a result, TILEN/EYLEN is expected to become the first domestically approved MRI-safe ICD with independent intellectual property rights. TILEN/EYLEN, as a core product of the National Key Research and Development Program funded by the Ministry of Science and Technology, aims to fill in domestic technological gaps. Its main technical advantages include: 1. Automatic MRI function: Significantly reduces discomfort caused by asynchronous mode and simplifies the MRI scanning process. 2. Remote follow-up: Based on low-power Bluetooth technology, a complete solution is built relying on domestic data centers to enhance patient compliance with follow-ups. 3. Industry-leading lifespan: Effectively reduces the risk of infection due to device replacement and lowers the long-term economic burden on patients. Sudden Cardiac Death (SCD) is a major cause of death globally, characterized by sudden loss of consciousness within 1 hour of acute heart-related symptoms as a result of natural death caused by heart problems. Several large clinical trials have confirmed that ICD is the most effective measure in preventing SCD. It can restore normal heart rhythm through stratified treatment, including high-energy defibrillation, during life-threatening malignant ventricular arrhythmias (such as VF or VT). The group's PLATINIUM series of ICD products was approved by the NMPA in September 2024, becoming the first domestically produced ICD to be approved for sale, offering Chinese patients more options for preventing and treating SCD and promoting the localization and widespread use of high-energy defibrillator devices in China's cardiac rhythm management field. The entry of TILEN/EYLEN into the NMPA Green Channel is expected to accelerate the localization process of MRI-safe ICDs.