SCIENTECH (02291) has announced that its wholly-owned subsidiary, Shanghai Shape Memory Alloy Material Co., Ltd., has obtained a medical device registration certificate (registration certificate number: Guoxie Zhun 20263132087) from China's National Medical Products Administration for its MemoCarna oxidized film single-rivet patent foramen ovale occluder product.

Patent foramen ovale (PFO) is typically asymptomatic, but severe cases of non-closure can present with various clinical manifestations, most commonly cryptogenic stroke and migraine, and it is one of the important causes of cryptogenic stroke. Transcatheter closure is an important treatment method for PFO, yet postoperative residual shunt remains a clinical challenge. Published studies show that the incidence of residual shunt after PFO closure is approximately 10% to 30%, and it is associated with an increased risk of stroke recurrence.

This product was independently developed by the company and features a "M+W" interlocking internal buckle and single-rivet concave disc design, an embedded waist structure, and a three-layer flow-blocking membrane design to enhance closure stability and reduce nickel ion leaching. It is available in 9 model specifications to accommodate different anatomical PFO closure needs, effectively reducing residual shunt after closure surgery and improving surgical success rates.

Together with the MemoSorb biodegradable patent foramen ovale occluder, which the company previously obtained medical device registration certification for, the approval and market launch of this product further enriches the company's product portfolio in the field of patent foramen ovale closure treatment, providing clinicians with interventional treatment options based on different technical approaches. In the future, the company will continue to deepen its focus on the field of structural heart disease interventional treatment, continuously advancing product research and development and clinical applications, and providing patients with more treatment options.