▷ Good news for patients with corneal blindness: The MIOK keratoprosthesis, which …


20.01.2022 – 02:51

Microkpro Medical

Beijing (ots/PRNewswire)

On December 7, 2021, the MIOK keratoprosthesis was approved by the NMPA, the Chinese Medicines and Medical Devices Regulatory Authority. The MIOK keratoprosthesis is the world’s first approved artificial cornea that does not require co-implantation of donor corneas. It is of great importance for the 60 million patients with corneal blindness worldwide, since the MIOK keratoprosthesis no longer makes it impossible to restore their vision and thus also relieves the relatives.

Corneal transplantation is one of the most important means of restoring the vision of patients with corneal blindness. However, there is a high risk of corneal transplant failure and postoperative complications, usually due to the complex immunological reactions due to incompatibility of a transplanted organ. Such risks are also unavoidable with other artificial corneas that require the co-implantation of donor corneas. The MIOK keratoprosthesis, an artificial cornea made of 100% non-biological materials and which does not require the co-implantation of donor corneas, is therefore an ideal option for the treatment of patients with corneal blindness.

The MIOK keratoprosthesis is mainly made of clear PMMA plastic with excellent optical properties and tissue compatibility. It is designed to restore sight to patients with corneal blindness by creating a transparent optical path through a clouded cornea in the treated eye.

Thanks to its special design and processing, the MIOK keratoprosthesis offers excellent performance in terms of transparency, translucency and durability, as well as high biocompatibility and ease of use in surgical interventions, allowing it to be quickly integrated into the surrounding tissue. Compared with conventional corneal transplantation and other artificial corneas, MIOK keratoprosthesis does not require co-implantation of donor corneas, which counteracts the global shortage of donor corneas and effectively reduces the risk of serious postoperative complications and immune rejection. In addition, the MIOK keratoprosthesis is indicated for patients with corneal blindness when corneal transplantation has failed or is at high risk of failure, particularly patients with corneal graft failure, corneal scarring/vascularization, chemical/thermal burns, autoimmune diseases (Stevens- Johnson syndrome, pemphigoid, etc.), symblepharon and severely dry eyes, etc. Therefore, MIOK keratoprosthesis enables effective treatment for patients with corneal blindness caused by a wide range of corneal injuries.

About Microkpro Medical

Beijing Microkpro Medical Instrument Co.Ltd. (Microkpro Medical), founded in 1997, is an artificial vision company dedicated to bringing back sight to the blind with high-tech means. Thanks to the long-term tireless efforts of its outstanding R&D team, Microkpro Medical has launched its own artificial cornea – the MIOK keratoprosthesis – and completed the NMPA approval on December 7, 2021. The NMPA is the Chinese regulatory agency for medicines and medical devices.

And Microkpro Medical has a GMP compliant facility at the Daxing Biological Pharmaceutical Industry Base in Beijing with an annual production capacity of 100,000 keratoprostheses in Class 10,000/ISO 7 clean rooms.

reference

  1. Notice from the National Medical Products Administration (NMPA) of China. https://www.nmpa.gov.cn/directory/web/nmpa/yaowen/ypjgyw/20211207172819157.html (First sentence of the first paragraph, second sentence)
  2. Official Weibo of the Australian Embassy in China. https://weibo.com/1918101143/JdrWO1Vwp (First sentence of the first paragraph)
  3. Official website of the Massachusetts Eye and Ear Center. https://masseyeandear.org/medical-professionals/keratoprosthesis (Second paragraph, third sentence)
  4. Technical test report from the Center for Medical Device Assessment f NMPA https://www.cmde.org.cn/directory/web/WS01/images/yMu5pL3HxKSjqENRWjIwMDA4NzijqS5wZGY=.pdf (Third paragraph, fourth paragraph, third sentence)

Photo – https://mma.prnewswire.com/media/1728418/image_1.jpg

Photo – https://mma.prnewswire.com/media/1727553/image_2.jpg

Press contact:

Jian Gong,
[email protected],
+86-18501361379

Original content from: Microkpro Medical, transmitted by news aktuell


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