MicroPort Zongying's IVUS System Receives NMPA Approval, Advancing Precision Coronary Intervention

Shanghai, China — On October 16, MicroPort Scientific Corporation (00853.HK) subsidiary Shenzhen MicroPort Image Medical Equipment Co., Ltd. (hereinafter referred to as "MicroPort^®Trace^®") Developed and produced intravascular ultrasound（Intravascular Ultrasound，IVUS）Diagnostic EquipmentDecypher™（Tianwen™) and disposable intravascular ultrasound diagnostic catheterOutsight^®（Departure^®), successfully approved for marketing by the National Medical Products Administration (NMPA) (Registration Certificate No. 20243062024, Registration Certificate No. 20243062034).

Decypher™（Tianwen™）Intravascular Ultrasound Diagnostic Equipment: With innovative design, it breaks through the withdrawal speed limitation of 10mm/s for similar products, reaching up to 40mm/s. This enables the fastest image acquisition in the industry, completing a 100mm vessel length scan within 3 seconds while ensuring clear images with a resolution of up to 20μm. It allows for thorough observation of the patient’s plaque and fine structures, assisting operators in providing high-quality and efficient guidance for precise interventions.Decypher™（Tianwen™）Adopting an integrated pull-up design, it is easy to load and unload, reducing the loss of additional consumables. When used in conjunction,Outsight^®（Departure^®）The disposable intravascular ultrasound diagnostic catheter, with its excellent passability and compatibility, can address different vascular lesions and facilitate rapid diagnostic decision-making.

With the changes in lifestyle and the aging population, the prevalence of cardiovascular diseases has significantly increased. Currently, coronary heart disease diagnosis mainly relies on angiography, which provides two-dimensional images of the arterial lumen and cannot comprehensively and accurately assess atherosclerosis. It also has anatomical limitations for left main trunk, ostial or bifurcation lesions, and may present deviations in evaluating eccentric plaques or diffuse plaques. IVUS (intravascular ultrasound) involves inserting a miniature ultrasound probe into the vascular lumen through catheter technology. By emitting ultrasound waves and capturing reflections, it provides real-time imaging of the vascular lumen, clearly showing the thickness of the vessel wall structure, the size and shape of the lumen, and precisely measuring the vascular diameter and cross-sectional area. It can even identify calcified, fibrotic, and lipid pool lesions. Therefore, IVUS provides a basis for further interventional treatment by operators to achieve optimized stent selection and precise therapeutic outcomes. At the same time, IVUS can confirm whether the implanted stent is well-apposed and expanded, whether there are edge dissections, tissue prolapse, physical loss, or stent compression after implantation. As the new "gold standard" for coronary artery examination, IVUS has become the primary intravascular imaging modality in cardiac catheterization labs. The 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes recommend intravascular imaging guidance for complex lesion evaluation as a Class IA recommendation, further stating that when indicated by ICA (coronary angiography), IVUS should be considered to evaluate the severity of moderate left main stenosis before revascularization. Increasing clinical experience and research results indicate that IVUS plays an important role in guiding lesion assessment, optimizing procedural strategies, and improving long-term prognostic outcomes.

Decypher™（Tianwen™）Intravascular Ultrasound Diagnostic Equipment &Outsight^®（Departure^®）The successful approval of the disposable intravascular ultrasound diagnostic catheter in China provides a powerful PCI diagnosis and treatment solution for clinical use. In the future, MicroPort^®Trace^®Will continue to adhere to quality leadership and innovation-driven development, committed to providing global patients and doctors with more high-quality, safe advanced medical imaging and treatment devices. Staying true to the original aspiration of wholeheartedly safeguarding every coronary heart disease patient, the company will offer more high-quality and affordable medical solutions to coronary heart disease patients through continuous innovation.