Core Viewpoint - The company has received formal notification from the National Medical Products Administration confirming that its nickel-titanium alloy patent ductus arteriosus (PDA) occluder has entered the special review process for innovative medical devices, marking the sixteenth product of the company to enter this process [1][2] Group 1: Product Details - The PDA occluder is designed for interventional treatment of congenital heart PDA and features a full nickel-titanium metal structure that allows for both "venous forward" and "arterial retrograde" release paths [2] - The product is made from woven nickel-titanium alloy wire and employs a self-expanding asymmetric double-disc structure, providing flexibility in choosing the implantation path based on patient conditions [2] - Compared to traditional forward pathways, the retrograde approach simplifies the procedure, reduces operation time, and offers better treatment options for patients with venous system contraindications [2] Group 2: Market Implications - The company holds independent intellectual property rights for the product, and clinical trials for registration in China are progressing steadily [2] - The entry into the special review process is expected to shorten the registration timeline, accelerating the product's market launch [2] - The anticipated launch of the product is expected to benefit PDA patients and expand the company's product range, thereby promoting growth in the medical device sector [2]