Group 1 - The National Medical Products Administration (NMPA) has announced the acceptance of the new generation implantable cardioverter-defibrillator (ICD) TILEN/EYLEN for special review, which is expected to be the first domestically approved MRI-safe ICD with independent intellectual property rights [1] - TILEN/EYLEN is a core product of a national key research and development project, aiming to fill the technological gap in the domestic market, featuring advantages such as automatic MRI functionality, remote follow-up capabilities, and industry-leading lifespan [1] - The ICD market is significant as sudden cardiac death (SCD) is a major global cause of death, and ICDs have been proven to be the most effective measure for preventing SCD, providing critical treatment during life-threatening arrhythmias [2] Group 2 - The company's PLATINIUM series ICD products received NMPA approval in September 2024, marking the first domestically approved ICD, thus expanding 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]
心通医疗-B(02160.HK):植入式心律转复除颤器进入创新医疗器械特别审查程序