微创心通-B:植入式心律转复除颤器进入创新医疗器械特别审查程序
Zhi Tong Cai Jing·2026-02-13 15:12

Group 1 - The core announcement is that MicroPort Cardiac Rhythm Management (MicroPort) has received a favorable review from the National Medical Products Administration (NMPA) for its new generation implantable cardioverter-defibrillator (ICD) TILEN/EYLEN, which is expected to enter the innovative medical device special review process [1] - TILEN/EYLEN is anticipated to be the first domestically approved MRI-safe ICD with independent intellectual property rights, addressing a significant technological gap in the domestic market [1] - The device features automatic MRI functionality, remote follow-up capabilities using low-power Bluetooth technology, and an industry-leading lifespan, which collectively aim to enhance patient comfort, compliance, and reduce long-term economic burdens [1] Group 2 - Sudden Cardiac Death (SCD) is a major global cause of mortality, and ICDs have been proven to be the most effective preventive measure against SCD, restoring normal heart rhythm during life-threatening arrhythmias [2] - The PLATINIUM series ICD products have already received NMPA approval in September 2024, marking the first domestically approved ICD, thus providing more treatment options for SCD in China and promoting the local development and application of high-energy defibrillator devices [2] - The entry of TILEN/EYLEN into the NMPA green channel is expected to accelerate the domestic production process of MRI-safe ICDs [2]

Innovation Medical-微创心通-B:植入式心律转复除颤器进入创新医疗器械特别审查程序 - Reportify