International Expansion Milestone: Shanghai Hanyu Medical's ValveClamp® Mitral Clip System Receives Marketing Approval in Indonesia

Mar 25, 2024 09:59 CST Updated 09:59

Hanyu Medical

Structural Heart Disease Interventional Devices and Electrophysiology Product R&D, Manufacturer

March21Recently, the first overseas product from Shanghai Hanyu Medical Technology Co., Ltd. ——"ValveClamp^®Mitral Valve Clip System"Obtained the approval from the Indonesian Ministry of Health (MOH) Registration Approval.

Shanghai Hanyu Medical Technology Co., Ltd."ValveClamp^®Mitral Valve Clip System"Composed of a mitral valve clip, delivery system, and transvalvular device. Among these, the delivery system consists of a delivery catheter, pusher, loader, catheter sheath, and dilator. This product does not require cardiac arrest or extracorporeal circulation during surgery, features a small incision, a short surgical approach, and direct positioning; moreover, it is guided solely by ultrasound intervention, ensuring that neither doctors nor patients are exposed to radiation.XRadiation impact. Its mitral valve clip has a larger capture range, which is beneficial for operation; it adopts a closed-loop design, making it difficult for the clip arms to separate, ensuring stable clamping. This product uses an apical surgical approach and is suitable for patients assessed by a professional cardiac team as having a high risk of surgical operation, and whose mitral valve anatomy is suitable for degenerative mitral regurgitation (MR≥3+) patients. The underlying diseases of these patients should not affect the clinical benefits brought by the reduction of mitral regurgitation.

Fig.- ValveClamp® Mitral Valve Clip System

As "going global" becomes2023The keyword for Chinese enterprise development in the year, Hanyu Medical has also actively participated in this wave. The approval of the Indonesian marketing authorization marks the beginning of Hanyu Medical's international journey, which is a milestone. Meanwhile, Hanyu Medical has also formulated the "Belt and Road" Heart Protection Journey plan, intending to...ValveClamp^®Extend to more countries, bringing more affordable and inclusive therapies to developing countries along the "Belt and Road".

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Shanghai Hanyu Medical Technology Co., Ltd.

Shanghai Hanyu Medical Technology Co., Ltd. (Hanyu Medical) was founded in2016At the end of the year, located in Minhang District, Shanghai. With the mission of "Defending Life, Benefiting the World," the company mainly engages in the research, development, production, and commercialization of interventional devices for structural heart disease and electrophysiology products.

In the field of interventional devices for structural heart disease, the company's innovative medical device "ValveClamp®The "Mitral Valve Clip System" has been2023Year9At the beginning of the month, it was officially approved by the National Medical Products Administration, becoming the first domestically produced mitral regurgitation interventional device approved for marketing in China.

The company has laid out a precise and diversified pipeline of products under research in this field: a novel atrial septal defect occluder.ReAces(Rui Ao) has completed clinical enrollment and is currently in follow-up; percutaneous mitral valve clip and delivery systemValveClaspIn2023Entered the National Innovative Medical Device Special Review Program in [Year], currently in clinical enrollment. The company aims to comprehensively address the unmet clinical needs in China's structural heart disease field, providing patients with high-quality, cost-effective integrated cardiac disease solutions to improve survival rates, life expectancy, and quality of life.