Seven Innovative Medical Devices Approved in March, Including Xinuopu's Cryoablation System

　　【Pharmaceutical Network Industry DynamicsAccording to the website of the National Medical Products Administration, in March, a total of 7 innovative medical device products have been approved for marketing. On March 31, two innovative products received approval for market entry: the cryoablation system and the disposable balloon-type cryoablation catheter registration application from Synaptic Medical Technology (Beijing) Co., Ltd.
 

Data shows that the cryoablation system consists of a cryoablation system host and a touch screen. The single-use balloon-type cryoablation catheter is composed of a balloon-type cryoablation catheter, a coaxial fluid connector tube, and a connecting cable. The cryoablation system is used in conjunction with the single-use balloon-type cryoablation catheter for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation in adult patients. The product uses a compliant, adjustable-diameter balloon, which is expected to improve the success rate of pulmonary vein occlusion.
 

Synaptic Medical is an innovative and international dual-driven cardiac electrophysiology enterprise, primarily addressing rapid arrhythmia-related conditions such as atrial fibrillation (AF). The cardiac electrophysiology industry mainly focuses on diagnosing and treating rapid arrhythmias like AF, a common persistent arrhythmia whose incidence increases with age. AF is a significant factor in triggering cardioembolic stroke and is also closely associated with the occurrence of heart failure and hypertension, representing a pressing challenge in the global field of cardiology.
 

Synaptic Medical's disposable balloon-type cryoablation catheter adopts a special fluid jet device and balloon pressure monitoring technology. The special fluid jet device ensures uniform temperature distribution on the surface of the front hemisphere of the balloon for effective ablation, while the balloon pressure monitoring technology ensures stable contact of the balloon and maintains stable internal pressure. This product effectively reduces the risk of balloon displacement due to pressure fluctuations during ablation, benefiting more patients with paroxysmal atrial fibrillation.
 

In addition to the above products, innovative medical device products approved in March also include the Transcatheter Mitral Valve Clip System from Enlight Medical Limited and the CO2 Contrast Pressure Injection Set from Amt Medical Device (Beijing) Co., Ltd. The Transcatheter Mitral Valve Clip System, an innovative product of Enlight Medical Limited, uses a percutaneous approach and is suitable for patients assessed by the cardiac team as having...Surgical OperationHigh-risk patients with degenerative mitral regurgitation (MR≥3+) and suitable mitral valve anatomy. The innovative CO2 contrast pressure injection set developed by Amet Medical Devices (Beijing) Co., Ltd. is suitable for individuals allergic to iodinated contrast agents, patients with chronic kidney disease stages 3 to 5, and patients with hyperthyroidism.
 

In addition, the registration application for the implantable ocular muscle neurostimulator of Super Vision Technology (Beijing) Co., Ltd. has been approved for improving congenital horizontal nystagmus symptoms in patients aged 8 years and above. The innovative product registration application for the implantable brain-computer interface hand motor function compensation system of Neuracle Technology (Shanghai) Co., Ltd. has also been approved. It is suitable for patients with quadriplegia caused by cervical spinal cord injury, assisting in achieving hand grip function compensation through a pneumatic glove device. The innovative product registration application for the bioabsorbable patent foramen ovale (PFO) closure system of Worry-Free Heartbeat Medical Technology (Shenzhen) Co., Ltd. has been approved. It is intended for patients aged between 18 to 60 who have experienced cryptogenic stroke due to PFO, where comprehensive evaluation excludes other mechanisms leading to stroke. When it is considered that PFO may have a causal relationship with ischemic stroke and the PFO exhibits high-risk anatomical features (atrial septal aneurysm or substantial right-to-left shunt), PFO closure is performed after joint decision-making by neurologists and cardiologists.
 

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