Core Insights - 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 procedure for innovative medical devices [1][2] - This product is the company's sixteenth to enter this special review process, indicating a strong pipeline of innovative medical devices [1][2] Product Details - The PDA occluder is designed for the 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 device is made from woven nickel-titanium alloy wire and employs a self-expanding asymmetric double-disc design, providing flexibility in implantation based on patient conditions [2] - Compared to traditional approaches, the retrograde access method simplifies the procedure, reduces operation time, and offers better treatment options for patients with venous system contraindications [2] Clinical and Market Implications - The company holds independent intellectual property rights for the product, and clinical trials for registration in China are progressing steadily [2] - The board believes that entering the special review process will 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 offerings, thereby promoting growth in the medical device sector [2]