B · Normal
[Bairen Medical: The aortic root expansion patch enters the special review process for innovative medical devices] On September 14th, Bairen Medical (688198.SH) announced that the company's independently developed aortic root expansion patch has been approved by the Medical Device Technology Review Center of the State Food and Drug Administration and has entered the special review process for innovative medical devices. This product is the first patch in China specifically used for aortic root enlargement surgery. It is designed to solve the problem of mismatch between the valve and the patient caused by too small annulus in SAVR patients. The product is made of finely woven polyester fabric as the base and covered with type I collagen coating. It is divided into two specifications: flat sheet type and cylindrical sheet type. Entering the innovation review process this time is expected to shorten the registration cycle, but it will not have a significant impact on recent performance. There is still uncertainty about product registration and launch.
A-share announcement express 🕐 2026-09-14 18:54

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