Shanghai, China — Recently, the Medical Device Technology Evaluation Center of the National Medical Products Administration (NMPA) issued the “Announcement on the Review Results of Applications for Special Review of Innovative Medical Devices (No. 3, 2026)”. The next-generation implantable cardioverter defibrillator (ICD), TILEN/EYLEN, developed by MicroPort CardioFlow Medtech Corporation (hereinafter referred to as “MicroPort CardioFlow”), has officially entered the special review pathway for innovative medical devices—commonly known as the national innovation “Green Channel”. It is expected to become the first domestically approved MR-conditional ICD with Bluetooth connectivity, offering an improved solution for the prevention and management of sudden cardiac death (SCD).

SCD is currently a major challenge in the prevention and control of cardiovascular diseases in China. According to statistics, approximately 800,000 cases of sudden cardiac death occur in China each year—equating to nearly two cases per minute on average. ICD is widely recognized as the “only effective” therapy for preventing sudden cardiac death. When a patient experiences life-threatening malignant ventricular arrhythmias—such as ventricular fibrillation or sustained ventricular tachycardia—the ICD can restore normal sinus rhythm through tiered interventions, including high-voltage defibrillation.

Currently, the global ICD market is experiencing steady growth, with a projected compound annual growth rate (CAGR) of over 7% from 2024 to 2029. In contrast, the Chinese ICD market remains in its early development stage and holds substantial growth potential. Over the past decade, the Chinese ICD market has achieved a CAGR of nearly 20%, reflecting strong growth momentum. In the coming decade, this market is expected to sustain rapid expansion, with an estimated CAGR of 25%.

The ICD possesses substantial clinical value. However, it has a high research and development barrier and is a highly technically demanding product in the field of cardiac rhythm management. On January 12, 1995, the first implantation of the DEFENDER™ ICD device—developed independently by MicroPort CardioFlow—took place in Strasbourg, France. This milestone laid the foundation for a revolutionary advancement in global cardiac rhythm management.

Currently, MicroPort CardioFlow holds several innovative technologies in the field of cardiac defibrillation. These include PARAD+™—clinically proven to deliver low rates of inappropriate shocks during defibrillation; AutoMRI™—which automatically adjusts the device’s operating mode during magnetic resonance imaging (MRI) to ensure patient safety; and Bluetooth connectivity, enabling seamless remote monitoring and real-time data transmission to enhance patient management efficiency. In October 2024, MicroPort CardioFlow’s new product, the PLATINUM™ ICD, received approval from NMPA, becoming the first domestically developed ICD approved in China. As of now, MicroPort CardioFlow has established a comprehensive product portfolio comprising five core ICD models. This product series serves as a cornerstone of the company’s business, contributing 20% of total revenue in 2025.

The successful launch of PLATINIUM™ marks the company’s first domestic breakthrough in the ICD field. Building on this achievement, MicroPort CardioFlow is accelerating its in-depth strategic expansion into high-end technology domains—particularly MRI compatibility. The National Key R&D Program project—“Research and Development of a Magnetic Resonance (MR)-Compatible ICD”—jointly submitted by MicroPort CardioFlow and institutions including the First Affiliated Hospital of Dalian Medical University, was approved by the Ministry of Science and Technology of China in 2022. As the core product of this project, TILEN/EYLEN is expected to become the first MR-compatible ICD with independent intellectual property rights approved in China, thereby filling a critical domestic technological gap.

AUTOMRI: Asynchronous mode OFF, enabled via algorithmic automation—minimizing patient physical and psychological discomfort while optimizing safety. Streamlines the MRI scanning workflow: most of the action occurs before the scan;

Remote Monitoring: A complete solution—built on domestic data centers—enhances patient adherence to follow-up appointments.

Industry-Leading Longevity: Effectively reduces the risk of infection associated with device replacement, lowers the long-term economic burden on patients, and provides a more intelligent, durable, and localized solution for the prevention and control of sudden cardiac death in China.

The inclusion of TILEN/EYLEN in the innovative medical devices 'Green Channel' will further solidify MicroPort CardioFlow’s commitment to 'Created in China' within its cardiac rhythm management business. Leveraging over 60 years of technological expertise and global presence in cardiac rhythm management, we will accelerate the comprehensive localization from R&D to production, deepen the commercialization process in China’s high-growth market, and contribute to the company’s revenue growth. At the same time, we aim to provide patients worldwide with innovative, integrated device management solutions covering the 'full etiology, all stages, and entire process' of heart failure.

About the "Green Channel"

The “Special Review Procedure for Innovative Medical Devices”, issued by the National Medical Products Administration (NMPA), is an important supportive measure to encourage and promote the innovative development of medical devices that possess significant clinical value and internationally leading technologies. Its purpose is to provide specialized communication and guidance on issues related to registration review. When the review criteria are met, innovative products are granted priority handling. This helps optimize the registration pathway and accelerate their market entry in China.