LIFETECH SCI (01302) announced that on August 20, 2025, the company received official written notification from the National Medical Products Administration confirming that its nickel-titanium alloy patent ductus arteriosus occluder (the Product) has entered the National Medical Products Administration's innovative medical device special review procedure (the Procedure). This product marks the company's sixteenth device to enter this procedure.
Patent ductus arteriosus (PDA) is one of the most common congenital heart diseases in clinical practice, accounting for approximately 12% to 15% of all congenital heart disease cases. If left untreated, it may lead to serious complications such as pulmonary hypertension and heart failure. Transcatheter PDA occlusion has gradually become the preferred treatment option for eligible patients due to its minimally invasive nature, safety profile, and rapid recovery advantages. However, given the varying structures and sizes of PDAs, along with different vascular conditions among patients, higher demands are placed on the adaptability of occlusion devices, creating greater clinical need for innovative devices that can accommodate multiple scenarios.
The Product is indicated for interventional treatment of congenital heart PDA and represents China's first domestically developed PDA occluder with an all-nickel-titanium metallic main structure capable of achieving bidirectional pathway deployment through both "antegrade venous" and "retrograde arterial" approaches. The Product is integrally braided from nickel-titanium alloy wire and features a self-expanding asymmetric double-disc structural design. Both left and right discs can be connected to the delivery cable, allowing flexible selection between "antegrade" or "retrograde" implantation pathways based on patient conditions. Compared to traditional antegrade pathways, the retrograde approach offers simpler operation, not only reducing surgical time but also providing better treatment options for patients with venous system contraindications, thus giving physicians more flexible solutions when facing different PDA pathological challenges.
The Group holds independent intellectual property rights for this product. Currently, the Product's registration clinical trial in China is progressing steadily, and the company expects to obtain more comprehensive evidence-based medical data to further confirm the Product's safety and efficacy.
The Board of Directors believes that the Product's entry into the Procedure will shorten its registration process and accelerate its market launch timeline. The expected market launch of this product will benefit PDA patients while expanding the company's product portfolio, thereby promoting the Group's development in the medical device sector.