Wuhan Weike Medical, a Chinese Potential Unicorn in Cardiac Intervention, Launches Self-Developed D-shufo™ PFO Occluder

Feb 22, 2024 17:50 CST Updated 17:50

Vickor

Structural Heart Disease Minimally Invasive Intervention Product Developer

Recently, Wuhan Vickor Medical Technology Co., Ltd. independently developedD-shufo™ New Generation PFO Occluder Receives NMPA Approval for Market Launch in China.D-shufo™ PFO Occluder, as the second domestically produced nickel-titanium alloy occluder approved for marketing in China, is alsoThe PFO Occluder with the Most Comprehensive Specifications Currently Available on the Market. This product 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.

What is Patent Foramen Ovale (PFO)?

The Foramen Ovale: A Natural Channel in the Heart's Atrial SeptumAbout 25% of the population has PFO., but most patients do not have obvious symptoms. However, the presence of PFO may pose a potential risk to health and life expectancy.

In recent years, with the deepening research on PFO, an increasing number of clinical syndromes have been associated with it, including cryptogenic stroke, transient ischemic attack, and migraine. Particularly in cases of cryptogenic stroke and migraine, studies have found that compared to individuals without PFO, patients with PFO face a significantly higher risk of stroke and migraine. These health issues not only cause immense physical and psychological suffering for patients but also impose a heavy burden on families and society.

To effectively address these issues, percutaneous interventional closure of the patent foramen ovale has become a recommended treatment method aimed at preventing the recurrence of stroke events and reducing the frequency of migraine attacks.

The demand for occlusion is increasing year by year.

In 2023, the annual number of PFO closure surgeries reached 60,000 cases, showing a steady upward trend each year.

PFO is one of the most common congenital cardiac anomalies in adults, with approximately one-quarter of adults having a patent foramen ovale. According to Frost & Sullivan, in 2021, the number of patients with cardiogenic stroke in China was approximately 4.5 million, and this number is expected to reach about 5.7 million by 2030. Closure of PFO can effectively prevent related strokes and alleviate symptoms of associated conditions.

D-shufo™ New Generation PFO Occluder

D-shufo™ Occluder has been meticulously optimized in both structure and material processing, demonstrating leading technological capabilities.

Mature materials, stable performance:Made of high-quality nickel-titanium alloy wire, it features excellent shape memory and superelasticity, providing stable clamping performance.

Structural Optimization, Effective Occlusion:Its unique disc-shaped inward-facing plate design effectively increases the success rate of treatment, bringing better rehabilitation hope to patients. In terms of material selection, the D-shufo™ occluder adopts high-quality nickel-titanium alloy, which has been clinically verified for over 20 years, ensuring long-term safety and effectiveness.

Upgraded Coating, Safe and Non-Allergenic:It is worth mentioning that the parylene coating covering the occluder surface effectively reduces the release of nickel ions, further enhancing the safety of the product.

D-The launch of the shufo™ occluder not only demonstrates China's innovative strength in the field of medical devices but also signifies that the treatment of patent foramen ovale (PFO) in China has entered a brand-new stage of development. Its superior performance and unique design provide a standardized and highly efficient new option for the clinical treatment of PFO, opening a new chapter in treatment.

Expert Comments on D-shufo™ Occluder

Professor Nian-Guo Dong from Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyIn this evaluation, the D-shufo™ occluder is a new generation of patent foramen ovale (PFO) occluder independently developed in China. It has been fully optimized in both structure and material processing. The disc-shaped inward-flaring 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 and coated with Parylene, 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 Feng Yuan from West China Hospital, Sichuan UniversityCommented: "As the 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 the endothelialization effect of 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 PFO closure device, while also bringing good news to patients who require PFO closure!"

Professor Yushun Zhang from the First Affiliated Hospital of Xi'an Jiaotong UniversityIt is noted that the PFO industry has undergone more than 20 years of development, and has now gradually moved towards technological maturity and stability. Behind this progress lies the close cooperation between clinicians and manufacturers, as well as the long-term safety and effectiveness demonstrated by nitinol 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 option for cryptogenic stroke. It is expected that this product will bring new breakthroughs to the PFO industry, promoting technological advancement and innovation in this field.

Wuhan Vickor Medical Technology Co., Ltd. was established 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 providing innovative medical device platforms for the entire cardiovascular cycle through R&D, technical services, production, and sales, it offers optimized products and treatment solutions for patients and doctors worldwide.

The products cover multiple fields, including atrial shunt devices for heart failure prevention and treatment, patent foramen ovale closure devices for the prevention of cardiogenic stroke, transcatheter aortic valve replacement systems for valvular disease treatment, as well as related surgical accessories and consumables. In the "2022 China Potential Unicorn Enterprise Research Report" released by Great Wall Strategy Consulting, Wuhan Vickor Medical Technology Co., Ltd. is regarded as ""Potential Unicorn Companies in China"The company has applied for more than 60 patents, including over 50 invention patents, 10 utility model patents, and 3 PCT patents. The related products have complete independent intellectual property rights.Atrial Shunt Device Receives NMPA "Special Review Procedure for Innovative Medical Devices" and FDA "Breakthrough Device Designation".

The震撼上市 of D-shufo™ will further promote the standardization of clinical treatment, while leading the treatment of patent foramen ovale in China into a new stage of development.Join Forces for Win-Win, D-shufo™ New Generation PFO Occluder Officially Launches Business Cooperation!

▲ Source of the article:Medical Device Innovation Network

▲ Please indicate the source above when reprinting.

Disclaimer: This article is intended solely for the purpose of information transmission and is for reference only. It does not constitute any advice on investment or treatment; please exercise caution. If the content, copyright, or other issues of the article are involved, to protect the rights and interests of both parties, please contact us and we will handle it immediately. If this article is reprinted by other platforms, the platform must take responsibility for the article itself; the Medical Device Innovation Network is not responsible for any secondary dissemination caused by reprints.

P R E V I E W

Sudden! 2700 Doctors Resign En Masse! Is This the Reason?

What Impact Does OpenAI's New Viral Sora Have on the Healthcare Industry?

May Lead to Death, Philips, Another Level One Recall!