Three New Innovative Medical Devices Approved for Market in China

　　【Pharmaceutical Network Product InformationAccording to the news released on the website of the National Medical Products Administration on September 29, three more innovative medical device products have been approved for marketing. The companies involved include Shenyang Pengyue Technology Co., Ltd. and Eyedeal Medical Technology Company Limited.
 

On September 29, the registration applications for two innovative products of Shenyang Pengyue Technology Co., Ltd. were approved by the National Medical Products Administration (NMPA) - a cardiac cryoablation device and a single-use sterile cryoablation probe. These two products are used together and mainly intended for the treatment of persistent atrial fibrillation in adult cardiac patients.
 

Data shows that the cardiac cryoablation device consists of a main unit, an argon gas delivery line, a helium gas delivery line, and an optional single-use sterile thermometer. The single-use sterile cryoablation probe comprises a probe tip, a handle, connecting tubes, and a temperature sensor.ThermocoupleComposition. The product utilizes the cooling phenomenon after argon gas throttling to rapidly freeze ablated myocardial cells, achieving the treatment of persistent atrial fibrillation. It has the advantages of rapid rewarming, vacuum insulation, dorsal temperature feedback, simple operation, and high safety, benefiting more patients with persistent atrial fibrillation.
 

On the same day, the registration application for the innovative product "Crosslinked Polyisobutylene Aspheric Intraocular Lens" by Eyedeal Medical Technology Company Limited was approved by the National Medical Products Administration. This product is suitable for vision correction in aphakic eyes following cataract removal surgery in adults.
 

Data shows that this product is a single-piece posterior chamber intraocular lens, foldable with dual C-loop haptics. The intraocular lens body and haptics are made of hydrophobic cross-linked polyisobutylene material, with an added UV absorber. The diopter range is +0.5 D to +34.0 D. The optical design of the intraocular lens is monofocal and aspheric.
 

In addition to the above two products, two innovative medical device products were approved for marketing in September. The registration application for Aiborn (Beijing) Medical Technology Co., Ltd.'s Extended Depth-of-Focus Intraocular Lens was approved on September 26. The innovative product "Transcatheter Aortic Valve System" by Suzhou Jiecheng Medical Technology Co., Ltd. was approved on September 2.
 

Among them, Eyedea's extended depth-of-focus intraocular lenses include non-preloaded intraocular lenses (Model: AE2UV) and preloaded intraocular lenses (Models: AE2UL22, AE2UL24, AE2UL28). The preloaded models consist of the non-preloaded AE2UV type intraocular lens and an injector. The intraocular lens is a one-piece, foldable, posterior chamber lens with modified L-shaped haptics. The main body and support parts of the intraocular lens are primarily made from ethyl acrylate (EA) and ethyl methacrylate (EMA) polymers, with cross-linking agent ethylene glycol dimethacrylate (EGDMA) added, and are treated with plasma surface modification technology. Both the front and back surfaces of the intraocular lens have a monofocal design, with the front surface featuring an aspheric high-order design and the back surface having a spherical design. This product is used for vision correction in aphakic adult eyes after cataract extraction surgery, improving intermediate vision by extending the depth of focus to reduce dependence on glasses.
 

Jiecheng Medical's "Transcatheter Aortic Valve System" is a transfemoral approach, featuring a movable positioning component that clamps the native aortic valve leaflets. The adjustable bending delivery system is suitable for complex anatomical structures such as horizontal hearts. It is applicable to patients assessed by the cardiac team in conjunction with a scoring system as having symptomatic, severe aortic valve regurgitation (severe aortic valve reflux), or combined with aortic stenosis, who are not suitable for conventional procedures.Surgical OperationPatients with valve replacement aged 70 years or older.
 

The centralized approval of these five innovative medical device products in September reflects the continuous enhancement of innovation capabilities in China's medical device field. These products have achieved continuous technological breakthroughs and ongoing performance optimization, providing more advanced medical equipment support for clinical use according to the treatment needs of different diseases, and bringing good news to a large number of patients.
 

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