Three Innovative Medical Devices Are Approved By NMPA
2021-07-07
In the last week of June, three innovative medical devices, recombinant type III humanized collagen lyophilized fiber, transccatheter aortic valve system and WEB aneurysmal embolization system, were approved by NMPA. China is encouraging the registration and marketing of innovative medical devices in recent years, please do not hesitate to contact us at info@ inspirativemed.com if you have any interest in bringing such innovative products into China. Detailed information about these medical devices is listed as below:
Product Name
Manufacturer
Indication
Function
Recombinant Type III Humanized Collagen Lyophilized Fiber
Shanxi Jinbo Bio-Pharmaceutical Co.,Ltd.
This product is used for facial dermal tissue filling to correct dynamic forehead wrinkles (including brow lines, forehead lines and crow’s feet).
It has higher cell adhesion than human type I and type III collagen, and forms a reticular fiber structure with good repair properties. It is expected to have broader clinical applications in vascular endothelium, endometrium, wound surface, oral mucosal repair and orthopedics and other fields.
Transcatheter Aortic Valve System
Peijia Medical Limited
For patients with severe calcified aortic stenosis who, as assessed by the cardiac team, require aortic valve replacement but are not suitable for conventional surgery to replace the valve.
The product is designed through the outer skirt to reduce the risk of paravalvular leakage; its valvular structure allows the frame to more effectively distract the narrow diseased annulus, while combining with the valve leaflets to avoid shielding the coronary vascular opening; the delivery device has the function of retrievability and repositioning, helping to solve the problem of “difficult positioning” and bringing better therapeutic effect to the patients.
WEB Aneurysmal Embolization System
Sequent Medical Inc.
For the treatment of ruptured and unruptured broad-necked bifurcated aneurysms.
After the implantation of the aneurysm with minimally invasive intervention, the implant expands automatically and prevents blood flow into the aneurysm through mechanical obstruction, providing a new treatment method for ruptured and unruptured wide-necked biforked aneurysm, and improving safety without the use of dual antiplatelet therapy after surgery。
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Classification Definition Principle of Recombinant Collagen Medical Products
Nomenclature Guideline for Recombinant Collagen Biomaterials
