Source: Heart Future; Editor: Seven Kite
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Recently,WYTD MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD.(abbreviated as "WYTD") independently developedConSuper™ Occluder Delivery SystemOfficially Obtained the Third-Class Medical Device Registration Certificate from the National Medical Products Administration(China Medical Device Registration Certificate No. 20243030961). This innovative productMainly used for the occlusion treatment of patent foramen ovale (PFO), atrial septal defect (ASD), ventricular septal defect (VSD), and patent ductus arteriosus (PDA).。
▲Source: WYTD Official WeChat Account
Heart occluders are usually made ofOccluderAnd/OrDelivery SystemCompositionThe mesh or umbrella structure of the occluder is generally made of metal materials, and the remaining parts are usually made of polymer materials. It is placed in areas such as heart defects, abnormal pathways, or special openings.And block this location to achieve the purpose of stopping abnormal blood flow.Used to treat congenital atrial septal defect, ventricular septal defect, patent ductus arteriosus, patent foramen ovale, and other diseases.The ConSuper™ Occluder Delivery System, as the first product to be launched in the integrated diagnosis and treatment layout for PFO, builds on the foundation of traditional delivery system designs.Calibration marks were made on the loader and conveyor cables.. This design not only achieves the precise release function of the device, but alsoMinimize Radiation Exposure to Both the Operator and the Patient。
In addition, the ConSuper™ Occluder Delivery System has a full range of models.Available in two bending types (45°, 180°), nine sizes (5F-16F), and sheath lengths ranging from 600mm to 800mm, capable ofFully meets the interventional delivery needs for PFO, ASD, VSD, and PDA occluders.
▲Source: Official WeChat account of WYTD
Congenital heart disease refers to the abnormal three-dimensional structure or function of the heart or intrathoracic blood vessels caused by obstacles in the formation or abnormal development of the heart and blood vessels during embryonic development, or the failure of channels that should automatically close after birth to do so.The morbidity rate of newborns in China is 5.4%~6.8%, while the morbidity rate of newborns in the United States is approximately 8.0%.。In the past, most congenital heart diseases required surgical treatment through traditional open-chest surgery.Over the past 20 years, with the continuous development of interventional treatment technologies and the ongoing improvement of related equipment,Interventional treatment has become the preferred choice for most common congenital heart diseases., such as atrial septal defect (ASD), ventricular septal defect (VSD), patent ductus arteriosus (PDA), etc.Preferred Radical Therapy。The clinical gold standard for congenital heart disease isInterventional Occlusion Procedure, the occluder is delivered to the corresponding site of congenital heart defect through peripheral vascular puncture and delivery catheter.According to Frost & Sullivan data,For the heart occluder market, the historical and expected sales revenue of China's congenital heart disease occluder products during the shown period is illustrated in the figure below.In 2020, the number of patients with congenital heart disease in China was 134,500, and it is expected to reach 145,500 by 2030.In 2020, the number of patients with congenital heart disease worldwide was 1.7 million, and it is expected to remain relatively stable by 2030.▲Source of the imageFrost & SullivanBy calculating the market size of cardiac occluders from 2018 to 2021, based on the number of congenital heart disease patients and product prices, the estimation was performed using exponential smoothing.It is predicted that the market size of cardiac occluders in China will reach 789 million yuan by 2025.Among them,The market share of patent foramen ovale (PFO) occluders is growing at the fastest rate., with a huge market space.▲Source of the imageMDCLOUDCardiac Occluder PassedDelivery SystemDelivered to the site of the cardiac defect, After deployment is completed, the cardiac occluder disconnects from the delivery system and remains in the target position.As of the date of publication,ChinaThe National Medical Products Administration has approved a total of 6 domestically produced occluder delivery systems and one imported occluder delivery system (Abbott).。Chinese manufacturers Lifetech Scientific, Shanghai Shape Memory (a wholly-owned subsidiary of Lepu Medical), and Huayi Shengjie occupy over 90% of China's occluder market, but there is still room for substitution in niche markets, such as left atrial appendage occluders.
▲Approved Delivery System for Occluders Made in China (Image Source: NMPA Official Website)）
WYTD MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD. was established in 2021 and is aFocus on interventional treatment of heart disease, especially structural heart disease.An innovative enterprise in the field. The founding team has深耕 (deeply engaged) in the structural heart disease industry for more than ten years, being one of the earliest pioneers in China to focus on this field, accumulating rich market experience and expert resources.At this stage, the products are mainly focused on Patent Foramen Ovale (PFO)., with the goal of being innovation-driven to provide a complete solution for PFO. The company has currently passed the certification as a National High-tech Enterprise (2023) and has been recognized as an internship base for college students, an internship base for Sichuan University, a high-growth enterprise in Pingshan District, and a technology-based small and medium-sized enterprise, among others.As of the date of publication, the company's financing history is as follows:
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
