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Recently, the D-shufo™ New Generation PFO Occluder independently developed by Wuhan Vickor Medical Technology Co., Ltd. has received registration approval from the National Medical Products Administration (NMPA) (Registration Certificate No.: GuoXieZhuZhun 20243130276).

D-shufo™ PFO Occluder is the third domestically produced patent foramen ovale occluder approved for marketing in China. It was independently developed by Wuhan Vickor Medical Technology Co., Ltd. The clinical trials were jointly led by Professor Nian-Guo Dong from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and Professor Yuan Feng from West China Hospital, Sichuan University. The impressive launch of D-shufo™ will further promote the standardization of clinical treatment while leading China.Treatment of Patent Foramen OvaleMoving Towards a New Stage of Development!
D-shufo™ New Generation PFO Occluder Product Advantages
Made from mature nickel-titanium alloy wire, its excellent shape memory and elasticity provide stable clamping performance. After 20 years of clinical validation, its safety and stability have gained widespread trust.
ParyleneSurface coating technology effectively blocks nickel ion release and reduces allergic reactions;
Disc-shaped concave structure that closely conforms to the atrial septum after deployment, reducing residual shunting;
Left disc with no rivet design promotes endothelialization and reduces the occurrence of left atrial thrombosis;
12 specifications and models, finely adjusted disc and waist diameters, unique left-large-right-small disc specifications, can adapt to complex patent foramen ovale shapes, improving the success rate of occlusion.

Expert Greetings

Professor Dong Nianguo
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
D-shufo™ Occluder is a new generation of patent foramen ovale (PFO) occluder independently developed in China. It has been comprehensively optimized in both structure and material processing. The disc-like inward-folded design enhances the stability and conformity after implantation, significantly improving the success rate of treatment. In terms of material selection, the D-shufo™ Occluder is made of high-quality nickel-titanium alloy, coated with Parylene on the surface, effectively reducing the release of nickel ions and further enhancing the safety of the product. We believe that with the widespread application of this product, more patients will benefit.

Professor Yushun Zhang
The First Affiliated Hospital of Xi'an Jiaotong University
The PFO industry has gone through more than 20 years of challenges and has now gradually moved towards technological maturity and stability. Behind this development is the close cooperation between clinicians and manufacturers, as well as the long-term safety and effectiveness demonstrated by nickel-titanium alloy occluders in clinical applications. The D-shufo™ PFO Occluder is the third domestically produced occluder approved in China for PFO-related indications, providing a new treatment device for cardioembolic stroke. It is expected that this product will bring new breakthroughs to the PFO industry and promote technological advancement and innovation in this field.

Professor Qin Yongwen
First Affiliated Hospital of Naval Medical University
We are delighted to see new devices entering the market in the PFO field. The D-shufo™ occluder is made from braided nitinol wires, and its material has been clinically validated for 20 years, proving to be safe, reliable, and trustworthy. Additionally, the complex structure of patent foramen ovale places high demands on the adaptability and precision of occluders. The new generation of D-shufo™ occluders comes in 12 different specifications, fully considering the clinical needs of various patients to ensure that every patient receives the most suitable treatment option. We look forward to witnessing the outstanding performance of the D-shufo™ occluder in clinical applications.

Professor Song Zhiyuan
Southwest Hospital, Army Medical University
In the field of cardiogenic stroke prevention, with the widespread adoption and application of PFO technology, the selection of indications has become crucial. Grasping the optimal indications is key to ensuring treatment effectiveness, thereby truly realizing the medical concept of "treating the heart and brain together" and benefiting more patients. The launch of the D-shufo™ occluder not only provides a new treatment option for cardiogenic stroke prevention but also injects new vitality into the long-term development of the PFO industry.

Professor Zhou Daxin
Zhongshan Hospital, Fudan University
In recent years, the concept of "treating the heart and brain simultaneously" has gained increasing clinical attention, becoming a research hotspot in cardiovascular and cerebrovascular diseases. The era of interventional prevention for cardiogenic stroke has arrived. Among these, the significance of patent foramen ovale (PFO) closure technology in preventing strokes has been clinically validated. The launch of Vickor's D-shufo™ occluder will enhance the standardized use of the device. With the widespread application of the D-shufo™ occluder, PFO closure technology is expected to be more extensively utilized in clinical practice, becoming an important method for the interventional prevention of cardiogenic stroke.

Professor Xianyang Zhu
General Hospital of Northern Theater Command
Prevention and treatment of PFO-related stroke have been a research hotspot in the past decade. A large amount of evidence shows that PFO closure benefits stroke patients; however, regarding PFO-related non-stroke conditions such as migraines,Decompression SicknessThe evidence is relatively limited. We look forward to the D-shufo™ PFO Occluder providing more evidence-based medical proof in its future applications, making a significant contribution to the treatment of patent foramen ovale.

Professor Feng Yuan
West China Hospital of Sichuan University
As a clinical researcher of the D-shufo™ PFO Occluder, I am very pleased to see the product's registration and market launch. With its excellent design, the D-shufo™ Occluder addresses many clinical pain points, reduces residual shunts, and optimizes endothelialization effects within the occluder. The D-shufo™ Occluder has a short learning curve for clinical application, is easy to operate, and highly safe, providing clinicians with an excellent interventional device for PFO closure and offering patients with indications a reliable solution.PFO PatientsBring Good News!
Introduction to Patent Foramen Ovale (PFO)
Patent Foramen Ovale (PFO) is a potential gap formed by the incomplete fusion and overlapping of the primary septum and secondary septum in the interatrial septum.The incidence of PFO in adults is approximately 20~34%.
Most PFO patients are asymptomatic, but the presence of PFO poses potential risks to health or lifespan.When the pressure in the right atrium is greater than that in the left atrium, a PFO may open, creating a right-to-left blood flow channel. Emboli from the systemic venous system (including thrombi, air emboli, fat emboli, etc.) can pass through the PFO into the systemic circulation, leading to a series of clinical symptoms such as migraine, ischemic stroke, myocardial infarction, peripheral vascular embolism, and decompression sickness.
An increasing number of studies have found that the risk of stroke, migraine, and other conditions is several times higher in people with PFO compared to the general population, and the incidence of PFO is also higher in those suffering from stroke, migraine, and similar conditions.
Percutaneous interventional closure of the foramen ovale has been recommended by relevant guidelines to prevent the recurrence of stroke events and alleviate migraine attacks, among others.
Vickor Medical
WuWuhan Vickor Medical Technology Co., Ltd. was founded in July 2018, focusing on major clinical needs in the cardiovascular field, especially in the minimally invasive interventional treatment of heart failure and structural heart disease.Committed to creating an innovative medical device platform for full-cycle cardiovascular solutions through R&D, technical services, production, and sales, providing optimized products and treatment options for patients and doctors worldwide.
The company's headquarters is located in Wuhan East Lake High-tech Zone, with an industrial chain layout upstream and downstream in Suzhou, Beijing, Shanghai and other places.The company's founders and research team are composed of experts in interventional structural heart disease, cardiac surgery, metal materials, braided device development, and medical device registration, forming a strong integration of medical, research, and enterprise collaboration.
Products cover multiple fields, including atrial shunt devices for heart failure prevention and treatment, patent foramen ovale occluders for cardiogenic stroke prevention, transcatheter aortic valve replacement systems for valvular disease treatment, and related surgical accessories and consumables.More than 60 patents have been applied for, including over 50 invention patents, 10 utility model patents, and 3 PCT patents. The related products possess complete independent intellectual property rights.Atrial Shunt Device Receives NMPA "Special Review Procedure for Innovative Medical Devices" and FDA "Breakthrough Device Designation".
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