MICOF Artificial Cornea by Beijing Mihe Medical Receives NMPA Approval as Innovative Medical Device

China Food and Drug News: On December 7, the National Medical Products Administration announced the approval of a product manufactured by Beijing Mihe Medical Instrument Co., Ltd.Innovative HealthcareThe registration application for the device "Artificial Cornea" provides a new approach for clinical treatment of patients with contraindications for traditional corneal transplantation.

"Artificial Cornea" is suitable for patients with bilateral corneal blindness for whom corneal transplantation is unlikely to succeed. This includes cases of failed corneal transplantation, severe corneal scarring and vascularization caused by chemical injuries, thermal burns, and explosive injuries, eyelid closure, severe autoimmune diseases (such as Stevens-Johnson syndrome and cicatricial pemphigoid), and corneal blindness caused by end-stage dry eye. The product is sterilized with ethylene oxide and is for single use.

It is reported that the "artificial cornea" consists of a mirror column and a stent. The mirror column is made of polymethyl methacrylate, and the stent is composed of a titanium stent wing and a polymethyl methacrylate stent base. This product is made of artificial materials, eliminating the need for donor corneas, which helps alleviate the current shortage of corneal donors in China. The product features a split design and staged implantation surgical method. The artificial cornea stent is implanted into the damaged corneal layer of the patient and anchored to the surrounding corneal tissue; the artificial cornea mirror column is fixed in the patient's eye by a threaded structure screwed into the stent, reducing the risk of harm to the affected eye during implant surgery and helping improve the product’s retention rate.

"Artificial Cornea" is the 33rd innovative medical device approved for marketing this year. So far, the National Medical Products Administration has approved 132 innovative medical devices, better meeting the public's demand for medical devices. Drug regulatory authorities will strengthen post-marketing supervision of innovative products to ensure patient safety in using medical devices. (Yan Ruoyu)

《China MedicineCopyright by the Publishing House of the Report, no reprinting or use without permission.

(Editor: Song Jiawei)