MP CARDIOFLOW-B (02160) announced that the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA) has published the results of its review for innovative medical devices. The review indicates a preliminary agreement to include the group's new generation implantable cardioverter defibrillator (ICD) system, TILEN/EYLEN, into the Innovative Medical Device Special Review Procedure, also known as the NMPA Green Channel. This acceptance positions the TILEN/EYLEN system to potentially become the first MRI-conditional ICD with independent intellectual property rights approved in China.

As a core product developed under a national key research and development program initiated by the Ministry of Science and Technology, the TILEN/EYLEN system is designed to address a technological gap in the domestic market. Its primary technical advantages include an automated MRI function that significantly reduces patient discomfort associated with asynchronous pacing modes and simplifies the MRI scanning process. It also features remote follow-up capabilities utilizing low-power Bluetooth technology and a domestic data center to offer a complete solution aimed at improving patient compliance. Furthermore, the device boasts an industry-leading service life, which effectively lowers the risk of infection from replacement procedures and reduces the long-term financial burden on patients.

Sudden cardiac death (SCD), characterized by an unexpected loss of consciousness due to cardiac causes occurring within one hour of the onset of acute symptoms, is a leading cause of mortality worldwide. Substantial clinical evidence from multiple large-scale trials has confirmed that ICDs are the most effective measure currently available for preventing SCD. These devices can restore normal heart rhythm through tiered therapy, including high-voltage defibrillation, when a patient experiences life-threatening malignant ventricular arrhythmias, such as ventricular fibrillation or tachycardia.

The group's PLATINIUM™ series of ICD products received NMPA approval in September 2024, marking them as the first domestically produced ICDs to reach the market. These devices have provided Chinese patients with more options for SCD prevention and treatment, advancing the local development and application of high-energy defibrillation devices in the field of cardiac rhythm management in China. The inclusion of the TILEN/EYLEN system in the NMPA Green Channel is expected to accelerate the localization process for MRI-conditional ICDs in the country.