Shanghai, China, 23 October 2024 - On October 16th, MicroPort® MicroImaging, a subsidiary of MicroPort Scientific Corporation (00853.HK), obtained approval from the National Medical Products Administration (NMPA) for the marketing of its Decypher™ IVUS Diagnostic System (Registration # 20243062024) and Outsight® Disposable IVUS Diagnostic Catheter (Registration # 20243062034).
The Decypher™ IVUS Diagnostic System set a new standard in the market with a pullback speed of up to 40mm/s, compared to the maximum of 10mm/s pullback speed found in other commercial IVUS systems. This allows for the fastest scan (image acquisition) of a 100mm-length vessel in just 3 seconds, all while providing sharp images with up to 20μm resolution. This system enables a comprehensive view of plaques and fine structures, aiding physicians in executing precise interventions efficiently. The Decypher™ is equipped with an integrated controller that simplifies the loading and unloading of the IVUS catheter, eliminating the need for additional disposable components and making it more environmentally friendly. Meanwhile, the Outsight® Disposable IVUS Diagnostic Catheter, recognized for its superior crossability and compatibility, effectively addresses various vascular lesions, allowing for quick and accurate diagnostic decisions.
As the new “gold standard” for coronary vessel examination, IVUS has become a crucial imaging tool used in catheterization laboratories. The 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes recommend IVUS as a Class IA tool for guiding complex lesions, and suggest its consideration for assessing moderate stenosis in the left main coronary artery prior to revascularization, as indicated by ICA (coronary angiography).1
The approval of the Decypher™ and the Outsight® in China provides clinicians with advanced solutions for PCI diagnostics and treatment. Moving forward, MicroPort® MicroImaging will continue to prioritize innovation, committing to providing safe, high-quality medical imaging and diagnostic equipment to patients and doctors worldwide.
About IVUS
Currently, coronary heart disease is primarily diagnosed through angiography in PCI procedures, which provides only two-dimensional imaging of the artery lumen and fails to fully visualize tissue details like atherosclerosis. Traditional angiography has limitations in visualizing certain types of lesions, such as left main ostial or bifurcation lesions, and can result in biased assessments of eccentric plaques, diffuse plaques, and other complex cases.
IVUS technology addresses these challenges by using an intravascular catheter with a miniature ultrasound transducer in the distal tip to scan the target vessels. It can clearly display the thickness of the vessel wall, the size and shape of the lumen, and accurately measure the vessel lumen diameter and cross-sectional area. Furthermore, it offers real time images where lesions with calcifications, fibrosis, and lipid pools can be readily recognized. IVUS provides physicians with crucial information, enabling more accurate stent selection and optimizing treatment outcomes. Additionally, IVUS can confirm proper stent apposition and expansion after implantation, as well as detect issues such as stent edge dissection, tissue protrusion, physical loss, and stent compression.
About MicroPort® MicroImaging
Founded in August 2019, MicroImaging (Shenzhen) Medical Equipment Co., Ltd. (MicroPort® MicroImaging), a subsidiary of MicroPort Scientific Corporation (00853.HK, MicroPort®), is dedicated to the research and development, production and supply chain integration of medical imaging products. MicroPort® MicroImaging is committed to creating the world’s leading imaging platforms and providing inclusive and accurate diagnosis and treatment solutions for hospitals and patients. The product pipelines cover non-invasive imaging systems and minimum invasive imaging systems, employing multi-modalities such as X-ray, nuclear magnetic resonance, ultrasound, near infrared etc. The graceful integration of multi-dimensional imaging system and AI algorithm would offer users a simple and reliable (imaging) diagnosis platform for precision treatment.
Reference
1. 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes: Developed by the Task Force for the Management of Chronic Coronary Syndromes of the European Society of Cardiology (ESC) and endorsed by the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal, Volume 45, Issue 36, 21 September 2024, Pages 3415–3537. https://doi.org/10.1093/eurheartj/ehae177