Recently, the National Medical Products Administration approved the registration applications of two innovative products, namely:
Disposable sterile urinary catheters from Taizhou Dubomai Medical Device Co., Ltd.;
Transcatheter aortic valve system from Peijia Medical Technology (Suzhou) Co., Ltd.

Among them, Peijia Medical Technology (Suzhou) Co., Ltd.'s transcatheter aortic valve system is the first domestically approved integrated positioning key transfemoral approach aortic valve regurgitation (AR) dedicated interventional treatment device.

Image source: Peijia Medical's official WeChat account

The product's aortic valve positioning key design is expected to enable precise valve positioning and anchoring; the large mesh design at the outflow end is expected to reduce the difficulty of subsequent coronary re-intervention in patients with low coronary artery disease; and the high-density diamond-shaped mesh design at the inflow end is expected to provide good occlusion.

Furthermore, the adjustable bend and rotatable design of the delivery system is expected to improve the accuracy of valve positioning and release. The product is suitable for patients aged 70 years or older who are assessed by a cardiac team as having symptomatic, severe aortic regurgitation (grade 3 or higher), are unsuitable for conventional surgical valve replacement, and are deemed such patients.

According to Peijia Medical, the product adopts the world's first integrated positioning key design and also has many product features and advantages such as 360° controllable rotation, dual anchoring mechanism, and better hemodynamics, overcoming the problems of difficult anchoring in previous products and equipment.

Another product, a disposable sterile urinary catheter, is also a domestically developed innovative medical device. According to the NMPA, this product is available in single-lumen, double-lumen, and triple-lumen types. The outer surface of the catheter contains a polylysine coating. Based on the charge interaction mechanism between polylysine and bacterial cell membranes, it exerts an antibacterial effect through direct contact, reducing bacterial colonization and growth on the catheter surface.

It is reported that Taizhou Dubomai Medical Device Co., Ltd., established in 2018, is dedicated to solving the problem of bacterial infection on the surface of medical devices. According to data from Yaozhi Medical Devices, in addition to the disposable sterile urinary catheter that has been approved for marketing this time, the company has already launched two other products: a disposable ultra-slippery urinary catheter and a recombinant collagen wound dressing.

With policy support and continuous technological development, the "value" of domestically produced medical devices is increasing, and the domestic medical device industry is continuously shining with new brilliance.

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