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2023Year9Month8Day，Shanghai Hanyu Medical Technology Co., Ltd. (hereinafter referred to as:Hanyu MedicalInnovative Medical Device ProductsValveClamp® Mitral Valve Clip SystemOfficially approved by the National Medical Products Administration.According to public information, the productForThe First Approved Mitral Regurgitation Interventional Device Produced in China。
# Mitral Valve Clip System Approved for MarketingNMPA Update Original Text as Follows:Recently, the National Medical Products Administration (NMPA) approved the registration of an innovative product, the "Mitral Valve Clip System," produced by Shanghai Hanyu Medical Technology Co., Ltd., after review. The product consists of a mitral valve clip, a delivery system, and a transvalvular device. The delivery system includes a delivery catheter, pusher, loader, catheter sheath, and dilator. When using this product, there is no need for cardiac arrest or extracorporeal circulation during surgery, with minimal incisions, shorter surgical access, and direct positioning. Additionally, the procedure is guided purely by ultrasound intervention, ensuring that neither doctors nor patients are exposed to X-ray radiation. The mitral valve clip offers a large capture range, facilitating operation, and features a closed-loop design, preventing the arms from separating easily and ensuring stable clamping.This product adopts the transapical surgical approach and is suitable for patients with degenerative mitral regurgitation (MR≥3+) who are assessed by a professional cardiac team as having a high risk for surgical procedures and whose mitral valve anatomy is appropriate. The underlying conditions of these patients should not affect the clinical benefits gained from reducing mitral regurgitation. The market entry of this product will provide more options for clinical treatment. The pharmaceutical regulatory authorities will strengthen post-market surveillance of this product to ensure patient safety in medical device usage.
It is reported that more than 20 papers have proven the superior effectiveness and operational convenience of the ValveClamp® Mitral Valve Clip System, which has already been clinically applied in dozens of hospitals in China. The original patent design of ValveClamp came from the team led by Academician Ge Junbo and was later transferred to Shanghai Hanyu Medical Technology Co., Ltd., which made further improvements and handled production.Hanyu Medical was founded in 2016 and is mainly engaged in the research, development, production, and commercialization of interventional devices for structural heart diseases and electrophysiology products. The company has independently developed and refined its unique core technology platform, covering the complete lifecycle of products from early design to process development and industrialization, laying a solid foundation for the steady progress of existing R&D projects and the continuous expansion of the product pipeline.The company's main core technologies include: (1) Design and production technology of precision steerable catheters; (2) Design and processing technology of novel cardiac occluders; (3) Design and processing technology of mitral valve clip devices; (4) Design and processing technology of transcatheter valve frames; (5) Design and processing technology of interventional cardiology devices for pets; (6) Design and control application technology of pulsed electric field catheter electrodes; (7) Preparation and processing technology of superelastic materials; (8) Precision processing system technology for implantable cardiovascular devices.Based on the company's strong R&D capabilities in the cardiovascular field, Hanyu Medical, a subsidiary of Shanghai Hanyu Medical Technology Co., Ltd., has developed interventional cardiology devices for pets and achieved initial commercialization both in China and overseas.According to the inquiry, from 2017 to now, the company has undergone 10 rounds of financing, with an amount exceeding one billion RMB, and the financing process has been stable.According to the introduction on Hanyu Medical's official website, the company's core product, ValveClamp, is designed based on the principles of classic surgical procedures. It uses a transcatheter surgical method to implant a clip that grasps the free edges of the anterior and posterior leaflets of the mitral valve, achieving an effect similar to the surgical edge-to-edge repair technique.The mitral valve clipper first utilizes the principle of mechanical clipping, where the upper jaw angle is larger than the lower jaw, and the surfaces of the upper and lower jaws that fit together are equipped with inclined teeth. This ensures that when the upper and lower jaws come together, they generate excellent clamping force, making it difficult for the clamped tissue to slip out between the jaws. When the upper and lower jaws are retracted into the closure ring, the two arms of the jaws move toward the midline, which in turn pulls the clamped tissue toward the midline while further enhancing the clamping force between the jaws. Secondly, it applies the principle of the excellent memory characteristics of nickel-titanium alloy, thereby enabling transcatheter delivery and implantation into the human body. The upper and lower jaws can be closed and retracted into the sheath outside the body, but once in the designated position, the mitral valve clipper is pushed out from the sheath, allowing the upper and lower jaws to naturally expand back to their original shape outside the body.
ValveClamp Clinical Application Steps:1. The clip device is delivered into the left atrium through the apex using a catheter;2. Adjust the position of the clamp so that the lower clamp presses against the mitral valve leaflet at the left ventricle.3. The upper clamp presses the leaflet down and aligns with the lower clamp to hold the valve in place;4. Both upper and lower clamps are fitted to the valve, the surgery is completed, and the catheter is removed.# Company Development History
In 2016, the company was established.
In 2017, completed angel round and Pre-A round financing.In 2018, completed Series A financing; successfully completed the first transapical mitral valve clip surgery in China, marking a new phase in the treatment of mitral regurgitation in China; completed 12 exploratory clinical trials (first-in-man), with a 100% success rate and 100% effectiveness rate; ValveClamp received the Best Innovation Award at the Cardiovascular Innovation Conference ICI 2018.In 2020, completed Series D financing.In 2021, completed D+ round financing; the puncturable occluder ReAces finished FIM trial enrollment; the transfemoral mitral valve clip ValveClasp entered the FIM clinical stage.In 2022, obtained the ISO13485:2016 Medical Device Quality Management System Certification.
Source: Heart Future
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