Skynor Medical's Peripheral Vascular Stent Receives NMPA Approval

Smart Medical Device Network NewsRecently, according to the official website of the National Medical Products Administration, Skynor Medical(Shanghai)Skynor Medical (Shanghai) Co., Ltd.'s peripheral vascular stent product has been approved, Registration Certificate No.: NMPA Approval20253131371。

It is reported that peripheral vascular stentsIt is a medical device used to treat peripheral arterial stenosis or occlusion, inserted into blood vessels through minimally invasive interventional surgery to help restore blood flow and improve ischemic symptoms. Its core function is to support the vessel wall and prevent elastic recoil, commonly used in the treatment of lesions in areas such as lower limb arteries, renal arteries, and carotid arteries.

The global market size for peripheral stent implantation is expected to reach2033will reach approximately71Billion USD, from2023Year's39USD billion growth, with a compound annual growth rate (CAGR) during the period (CAGR) for6.1%, the forecast period is2024Year to2033Year.

Peripheral Artery Disease (PAD) is a common cardiovascular issue where narrowed arteries restrict blood flow to the lower extremities (legs). When a person hasPADWhen the blood flow to the limbs (mainly the legs) is insufficient to meet the body's needs, it leads to a series of symptoms, the most common of which is leg pain during walking (intermittent claudication).

Peripheral stents are small, tubular metal scaffolds that can be implanted into peripheral blood vessels to relieve narrowing or blockages in arteries or veins, thereby improving blood flow. Stents are typically made of nitinol and can be bare, drug-coated, or covered with prosthetic material. Usually, a balloon (angioplasty) is first used to flatten the obstruction against the vessel wall, making it easier for the stent to expand.

Stents for peripheral arteries are commonly used in conjunction with balloon angioplasty. Peripheral stents keep blocked or occluded arteries open to allow blood to flow through. A stent is a small mesh-like metal tube that props the artery open and remains permanently in place. The stent is inserted into the peripheral artery via a catheter.

Recent technological advances can help prevent restenosis, which is the re-narrowing of blood vessels. Drug-eluting stents can now be used (DES) and balloons, which are coated with drugs to ensure good blood circulation in the treatment channel. Peripheral vascular disease is a chronic condition that is often associated with other diseases such as coronary artery disease or diabetes.

2024Year12Month19On the 5th, the fifth batch of centralized bulk procurement of high-value medical consumables organized by the state produced the selection results in Tianjin, including two types of products: cochlear implants and peripheral vascular stents. The total demand for peripheral vascular stent consumables was...25.810,000,18Both foreign and domestic companies were selected, including globally renowned foreign enterprises such as Conti Medical, ConvaTec, Abbott, Boston Scientific, and Biotronik, as well as domestic companies like Skynor Medical (Shanghai) Co., Ltd. and GuiChuang TongQiao, ensuring a rich and diverse product supply.

. Foreign-funded enterprises have shown high enthusiasm for participation, among all4Group (Cochlear Implants and3A peripheral vascular stent group) was selected as the top choice by a leading foreign-funded enterprise.

Data shows that Skynor Medical(Shanghai)Co., Ltd.( Skynor Medical)Founded in2014Year8Month, located in the Zhangjiang Science City International Medical Park, is a high-tech enterprise focused on the research and development and manufacturing of stroke and peripheral vascular interventional medical devices, committed to providing doctors and patients with high-quality integrated surgical instrument solutions. The company currently has office, R&D, and production facilities exceeding3000Square meters, all in compliance with the National Medical Products Administration andISO13485Quality System Requirements.

Existing staff of over120people, among whom the core management team all have more than ten years of extensive experience in well-known medical enterprises at home and abroad, engaging in R&D, quality control, production, marketing, etc. The R&D, quality, and clinical registration staff number approximately40%. Currently, the company has obtained several Class III medical device productsNMPARegistration Certificate and EUCECertification,

During this period, the company received strong support from multiple science and technology funds from the Shanghai Municipal Science and Technology Commission, the Pudong New Area Science and Technology Commission, and Zhangjiang Science City, and obtained"High-tech Enterprise in Shanghai", "Specialized, Precise, Unique and Innovative Enterprise in Shanghai",2021First Prize in the 4th China Medical Device Innovation and Entrepreneurship Competition"2021Annual Investment Value Award of the 9th China Innovation and Entrepreneurship Competition in [Year]"2020"Annual Innovation and Entrepreneurship Outstanding Enterprise," "Pudong New Area Key Entrepreneurial Enterprise," and many other honors.