Source: Heart Future; Editor: Evan
Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently, the Medical Device Technology Evaluation Center of the National Medical Products Administration releasedPublic Notice of the Review Results for the Special Review Application of Innovative Medical Devices (No. 7, 2024), among which,Skynor Medical ( Shanghai ) Co.,Ltd(Abbreviation:“Skynor Medical"）independently developed by Skynor Medical (Shanghai) Co., Ltd."Intracranial StentApproved.Enter the "Green Channel" for special review of innovative medical devices。
# SkyPort Intracranial Stent
Intracranial StentIt is a medical device specifically designed for intracranial blood vessels, mainlyUsed to treat conditions such as intracranial vascular stenosis or intracranial aneurysms. Intracranial stents canImplanted through endovascular interventional surgery to help restore normal blood flow in the vessel and prevent re-narrowing or rupture of the vessel.The SkyPort Intracranial Stent, which has entered the innovation channel this time, is a neurovascular intervention product by Skynor Medical.Intracranial Aneurysm Treatment SolutionsOne of the important products. This product isSelf-expanding Vascular Stent, usingUniqueSpecial Helical Structure, with excellent flexibility and wall apposition,Better conform to the artery carrying the tumor. At the same time, the stent has very goodFull Visibility Performance, which is beneficial for the operator to perform the procedure and accurately deploy the stent.July 2023Skynor Medical's "SkyPort Intracranial Stent" inThe First Case of Clinical Trial Enrollment Completed by Henan Provincial People's Hospital, the study was conducted through a prospective, multi-center clinical trialEvaluation of the Safety and Efficacy of Intracranial Stents for the Treatment of Intracranial Aneurysms, the coordinating investigator of this study is Professor Tianxiao Li, a renowned neurointerventional expert in China.This surgical case was successfully completed by Professor Li Tianxiao and Professor Xu Bin from Henan Provincial People's Hospital. The patient's intracranial aneurysm was located at the junction of the left internal carotid artery, classified as a typical wide-necked aneurysm.Originated from Henan Provincial People's Hospital
Professor Li Tianxiao highly praised the product after the surgery.: "Skynor Medical's SkyPort Intracranial Stent adopts an innovative design, featuringHigh Flexibility and High VisibilityCharacteristics. The stent delivery process was smooth, with accurate positioning and good wall apposition after deployment. The stent was clearly visible under imaging, and postoperative aneurysm occlusion was dense, with no significant contrast agent leakage observed in the aneurysm cavity.The surgical treatment was very effective.。Currently, all intracranial aneurysm stents used in clinical practice are imported products.，Hope SkyPort stent completes clinical trials and registration as soon as possible, and launches to benefit patients.。”
# Overview of Product Tracks
TheoreticallyThere are more people with cerebral infarction than myocardial infarction., justThe difficulty of neurointerventional surgery is much greater thanPercutaneous Coronary Intervention (PCI), There has been a lack of effective clinical evidence proving that neurointervention is superior to drug treatment. However, in recent years, with the iterative upgrading of consumables, clinical evidence in the interventional field has gradually increased. Manufacturers have also invested more research and development funds into new products. As more mature products become available,The neurointervention industry will experience more rapid development in the future.。
Intracranial Aneurysm (IA) refers to the cystic bulging of the intracranial arterial wall, mostly formed by localized weakness of the arterial wall and blood flow impact, making it highly prone to rupture and bleeding. Intracranial aneurysm is one of the most common and severe diseases in hemorrhagic cerebrovascular disorders.The disease has35% of cases result in severe disability, and the detection rate among the 35-75 age group in China is 9%.The mortality rate of patients with ruptured intracranial aneurysms is as high as 70%.。Before the advent of intracranial stents, coronary stents were commonly used in clinical practice to treat intracranial aneurysms, primarily balloon-expandable stents. Although clinically, balloon-expandable stents have shown relatively good treatment outcomes for sidewall aneurysms on straight intracranial vessels;But due to the lack of flexibility in balloon-expandable stents, it is more difficult to pass through the tortuous and slender parts of intracranial blood vessels.For intracranial vascular bifurcation aneurysms, which account for a significant proportion of intracranial aneurysms, the treatment capability of balloon-expandable stents is somewhat insufficient.In recent years, with the operation becoming more convenientSelf-expanding Intracranial Stent Successfully Launched, providing more device options for the clinical treatment of intracranial bifurcation aneurysms. The self-expanding intracranial stent is a new type of medical device with active expansion and inflation capabilities. It can provide support for the coils filled into the aneurysm cavity after being released at the neck of the aneurysm, preventing coil prolapse and improving the efficiency of embolization treatment.StrykerTheWinspan Stent is a dedicated self-expanding stent used for the treatment of intracranial vascular stenosis., relying on the delivery catheter and open-loop design, it has good support and release stability.CurrentlyNo related intracranial aneurysm stents have been approved for marketing in China.。Originated fromHenan Provincial People's HospitalJanuary 2022,Under Minimally Invasive Brain ScienceMinimally Invasive Shentong Medical Technology (Shanghai) Co., Ltd.Independently DevelopedRebridge® Fully Visible Intracranial StentPre-market Clinical Research PROMISE ProjectCompletion of First Patient Enrollment, marking that the development of Rebridge® has entered the clinical enrollment stage.Rebridge®Fully Visible Intracranial StentThe First Chinese-Made and Entered Clinical TrialFully Visible Aneurysm Embolization Assist Stent。
# Skynor Medical
Skynor Medical (Shanghai) Co., Ltd. was established in August 2014 and is located in the Zhangjiang Science City International Medical Park.Is a company focused onR&D and Manufacturing of Stroke and Peripheral Vascular Intervention Medical DevicesA high-tech enterprise dedicated to providing high-quality, integrated surgical instrument solutions for doctors and patients.Existing office, R&D, and production space exceeds 3000 square meters, all in compliance with the requirements of the National Medical Products Administration and the ISO13485 quality system.The core management team of the company 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. Approximately 40% of the staff are involved in R&D, quality control, and clinical registration. Currently, the companyMultiple Class III medical device products have obtained registration certificates from the National Medical Products Administration and EU CE certification.。The company has 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. It has also been awarded numerous honors, including "Shanghai High-tech Enterprise," "Shanghai Specialized, Refined, Unique, and Innovative Enterprise," "First Prize in the 2021 Fourth China Medical Device Innovation and Entrepreneurship Competition," "Annual Investment Value Award in the 2021 Ninth China Innovation and Entrepreneurship Competition," "Outstanding Innovation and Entrepreneurship Enterprise of 2020," and "Key Entrepreneurial Enterprise in Pudong New Area."
