Two Innovative Cardiovascular Medical Devices Approved in China on the Same Day as Companies Advance IPO Filings

　　【Pharmaceutical Network Product InformationAccording to the news released on the website of the National Medical Products Administration on March 24, two innovative medical devices have been approved for marketing in China, including the transcatheter mitral valve clip system developed by Enlight Medical Limited (Shanghai) and the CO2 contrast pressure injection kit created by Amet Medical Device (Beijing) Co., Ltd. The approval of these two innovative products will bring new treatment options to relevant patients.
 

Among them, the transcatheter mitral valve clip system, an innovative product of Enlight Medical Limited (Shanghai), uses a percutaneous approach and is suitable for patients assessed by the cardiac team as havingSurgical OperationHigh-risk patients with degenerative mitral regurgitation (MR≥3+) and suitable mitral valve anatomy.
 

Data show that the product is composed of a mitral clip and catheter delivery system, and a steerable guiding catheter. The mitral clip and catheter delivery system consist of a mitral clip, delivery catheter, and steerable sheath. The materials of the mitral clip components include cobalt-chromium alloy, nitinol, titanium alloy, pure titanium, and PET. The steerable guiding catheter consists of a guiding catheter, dilator, locking screw, and silicone pad. The mitral clip and catheter delivery system are divided into Type I catheter delivery system and Type II catheter delivery system according to the synchronized control clip or independently controlled clip function. The steerable guiding catheter is divided into Type I steerable guiding catheter and Type II steerable guiding catheter based on handle differences.
 

AMT Medical Device (Beijing) Co., Ltd. Innovative Carbon Dioxide Contrast Pressure Injection Set is suitable for individuals allergic to iodinated contrast agents, patients with chronic kidney disease stages 3 to 5, and patients with hyperthyroidism.
 

Data shows that the product consists of a contrast injector, infusion tubing, and a double-lock port.FilterComposed of three parts. The contrast injector is equipped with a 6% (Luer) internal conical connector (inlet) with a locking device and a diaphragm.Pressure Gauge, switch knob, shell, screw-type adjustment handle, 6% (Luer) external conical connector with locking device (outlet), gas storage cylinder, and piston seat. Product accessories include infusion tubing and dual-lock filter. This product is used for angiography by injecting carbon dioxide (purity ≥ 99.999%) into the renal artery, iliac artery, lower limb artery, forearm vein, inferior vena cava, and iliac vein.
 

In recent years, driven by favorable national policies, innovative medical device products in China have been emerging one after another. According to statistics, a total of 412 innovative products have been approved for marketing so far. Only in March, apart from the above two products, the registration application for Super Vision Technology, Inc.'s implantable ocular muscle neurostimulator was approved for improving congenital horizontal nystagmus symptoms in patients aged 8 years and above. The registration application for Neuracle Technology (Shanghai) Co., Ltd.'s implantable brain-computer interface hand motor function compensation system was also approved, applicable to quadriplegic patients caused by cervical spinal cord injury, assisting in achieving hand grasp function compensation through pneumatic glove devices. The registration application for Worry-Free Heartbeat Medical Technology (Shenzhen) Co., Ltd.'s degradable patent foramen ovale closure system was also approved, used for patients aged 18 to 60 with patent foramen ovale who have experienced cryptogenic stroke. After comprehensive evaluation excluding other mechanisms leading to stroke, it is considered that PFO may have a causal relationship with ischemic stroke and PFO has high-risk anatomical features (atrial septal aneurysm or large right-to-left shunt). The decision to perform PFO closure is made jointly by neurologists and cardiologists.
 

The approval of these two innovative devices further improves the innovative layout of high-end medical devices in China. With the continuous implementation of innovative products, China's medical device industry will continue to break through technological bottlenecks, providing patients with more accurate, safer, and more accessible medical services.
 

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