Recently,Vickor's D-shant® Atrial Shunt Device Receives FDA "Breakthrough Device" Designation for the Treatment of Moderate to Severe Chronic Heart Failure, Reduced Ejection Fraction (HFrEF), Elevated Left Atrial Pressure, and Patients with a Recent History of Ineffective Standard Medical Therapy, Becoming the First Atrial Shunt Device in China to Receive Such Designation.This not only represents the international recognition of the innovative nature and clinical value of the D-shant® atrial shunt, but also further accelerates the progress of Vickor's global layout.
Breakthrough Medical Device Certification
"Breakthrough Device Designation" is the "green channel" initiated by the U.S. Food and Drug Administration (FDA) in 2015 to accelerate the development and review process of innovative medical devices. The FDA's "Breakthrough Device Designation" represents the world's top level of technological innovation.The FDA "Breakthrough Device Designation" must meet two key criteria: "First, it must be an original technology on a global scale that can more effectively treat or diagnose life-threatening or irreversibly debilitating human diseases or conditions; second, there must be no approved alternatives, or it must demonstrate significant advantages over existing approved or alternative solutions, with device availability being in the best interest of patients."The FDA will offer priority review for device development and clinical trial protocols, support from a review team, and services related to commercialization decisions for products designated as “Breakthrough Medical Devices.”
Vickor D-shant®Atrial Shunt Device
Atrial shunt devices are an emerging international therapy for heart failure. Currently, three overseas companies have received CE certification internationally, while no companies have been approved in China. A series of evidence-based medical clinical trials have fully demonstrated the efficacy and safety of atrial shunt devices in heart failure treatment.Vickor's D-shant® Atrial Shunt is a Chinese implantable atrial shunt product with independent intellectual property rights. Due to its innovation and potential therapeutic advantages, it has been included in the National Innovative Medical Device Approval Green Channel.After rigorous clinical trials, it demonstrated significant therapeutic effects, effectively improving the hemodynamics of heart failure patients, controlling the progression of heart failure, and enhancing the cardiac function of patients. Long-term follow-up results show that patients have excellent prognosis and their quality of life has significantly improved. The D-shant® atrial shunt device, with its unique advantages, brings a new solution to heart failure treatment and successfully addresses the pain points of traditional therapies.
Interventional Retrievable, Secondary Intervention
The product, made from mature nickel-titanium alloy materials and utilizing a special braiding process, can be repeatedly retrieved during implantation. It is safe, reliable, and easy to operate, reducing the risk of detachment during surgery, providing the feasibility of intraoperative replacement, lowering the incidence of long-term stenosis and occlusion, and ensuring the long-term effectiveness of the product.
Internally-embedded disc design, nut eccentrically transverse
Reduce the risk of detachment, accelerate endothelialization, and reduce the risk of device embolization.
Stronger radial support, multiple specifications of diversion apertures
Formulate diversified, precise, and stable shunt orifices for different patients, reduce the possibility of shunt closure, and meet various treatment needs.
The number of patients with heart failure is increasing year by year.
Heart failure has always been a difficult clinical problem. Heart failure is the end-stage of the development of various cardiovascular diseases, characterized by poor prognosis, limited treatment options, and high patient mortality, and is known as the "final battlefield" of cardiovascular diseases.Approximately 2% of adults worldwide suffer from heart failure, with the prevalence increasing with age. Patients with heart failure often require hospitalization and experience a significantly reduced quality of life due to symptoms such as shortness of breath, fatigue, and depression. Moreover, the prognosis for this condition is poor, with more than half of patients dying within five years.
According to a recent study published in the European Journal of Preventive Cardiology, the number of heart failure patients worldwide increased from 33.5 million in 1990 to 64.3 million in 2017. In China, the number of heart failure patients aged over 35 reached 13.7 million. With the aggravation of population aging in China, the number of heart failure patients continues to rise, imposing a significant burden on both families and the national medical insurance system, highlighting a clear clinical treatment demand.
Clinically, atrial shunt surgery generally involves the use of a puncture needle and sheath to perform puncture and create a hole in the patient's atrial septum. Balloon dilation is then used to enlarge the aperture, and an atrial shunt device is implanted to maintain the aperture.Through this percutaneous interventional minimally invasive approach, it reduces left atrial pressure overload without significantly decreasing left heart output or significantly increasing right heart load, alleviates pulmonary congestion and dyspnea, and improves patients' clinical symptoms, exercise tolerance, and prognosis. The procedure is convenient, safe, and effective, with broad indications and easy promotion, and is expected to become a milestone technology in heart failure treatment, changing the survival status of a large number of heart failure patients.
In the future, Vickor will continue to focus on the field of heart failure treatment, committed to developing more innovative medical devices with independent intellectual property rights, providing safer and more effective treatment options for patients worldwide.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 this article are involved, to ensure the rights and interests of both parties, please contact us, and we will handle it immediately. If this article is reprinted by any platform, the platform shall be responsible for the article itself. The Medical Device Innovation Network is not responsible for any secondary dissemination caused by reprinting.PAST/ISSUE/REVIEW
