Zhitong Finance App News, Xintai Medical (02291) announced that Shanghai Shape Memory Alloy Material Co., Ltd., a wholly-owned subsidiary of the company, has obtained a medical device registration certificate from the China National Drug Administration for memoCarna® oxide film single riveted oval hole unclosed occluder products (registration certificate number: State Equipment Registration No. 20263132087).
Patent foramen ovale (“PFO”) is usually asymptomatic, but if not closed, various clinical manifestations may occur. Unexplained stroke and migraine are the most common, and are one of the important causes of cryptogenic stroke. Transcatheter blockage is an important treatment for PFO, and residual flow after surgery is still a clinical problem. Open studies have shown that the incidence of residual flow after PFO occlusion is about 10% to 30%, and is associated with an increased risk of recurrence of stroke.
The product is independently developed by the company. It uses an “M+W” fitting inner buckle and a single-rivet concave plate design, a built-in lumbar structure, and a three-layer flow barrier film design to improve blocking stability and reduce nickel ion precipitation, and provides 9 models to meet the PFO blocking requirements of different anatomical forms, which can effectively reduce residual flow after blocking surgery and improve the success rate of surgery.
Together with the memoSorb® biodegradable ovalbular hole unclosed occlusion device, which the company has previously obtained a medical device registration certificate, the approval and marketing of this product further enriches the company's product portfolio in the field of unclosed fallopian hole treatment, providing clinical interventional treatment options with different technical paths.
In the future, the company will continue to be deeply involved in the field of interventional treatment of structural heart disease, continue to promote product development and clinical application, and provide patients with more treatment options.