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] Product Overview - The PDA occluder is designed for interventional treatment of congenital heart PDA and is the first domestic product capable of dual-pathway release, allowing both "venous forward" and "arterial retrograde" approaches [2] - The product features an all-nickel titanium metal structure woven from nickel-titanium alloy wire, utilizing a self-expanding asymmetric double-disc design, which provides flexibility in choosing the implantation path based on patient conditions [2] - Compared to traditional forward pathways, the retrograde approach simplifies the operation, shortens surgery time, and offers better treatment options for patients with venous system contraindications [2] Clinical and Regulatory Progress - 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 and accelerate the product's market launch, benefiting PDA patients and expanding the company's product range in the medical device sector [2]