Lanmu Medical Enters NMPA's Innovative Medical Device Review Pathway with Glaucoma Drainage Implant
Purevision Medical
Developer of Ophthalmic Disease Treatment Products
Medpark Park Enterprises
Purevision Medical Glaucoma Drainage Device
Approved by the National Medical Products Administration (NMPA)
Officially entered after the public announcement period on February 10.
Special Review Procedure for Innovative Medical Devices
The World Health Organization has listed glaucoma as the world's leading irreversible blinding eye disease. The number of people affected globally reached 88 million in 2020, and with the aging population, the global prevalence of glaucoma continues to grow steadily at a rate of 3% per year. It is projected that by 2040, the global number of glaucoma cases will reach 110 million. Based on the etiological mechanisms, disease prognosis, and progression, the current effective clinical measures involve using various methods to control intraocular pressure to achieve an individual’s target eye pressure level while protecting the optic nerve and tissues, preventing optic nerve damage, and preserving visual function. Among the treatment methods for glaucoma, the primary approaches include medication, laser treatment, and surgical intervention.
The glaucoma drainage device approved this time is the AqueFish® Glaucoma Schlemm's Canal Drainage Stent (glaucoma drainage device) independently developed by Purevision Medical. It is also one of the few stent products internationally that can be simultaneously suitable for both angle-closure glaucoma and open-angle glaucoma, and is one of the rare minimally invasive glaucoma surgical instruments based on the original innovative surgical techniques of Chinese doctors.
AqueFish® Glaucoma Schlemm's Canal Drainage Stent (Glaucoma Drainage Device)
In addition to the aforementioned glaucoma products, Purevision Medical has also actively expanded into innovative therapeutic devices in other ophthalmic fields, such as glaucoma surgical auxiliary instruments, cataract surgical auxiliary instruments, and portable dry eye treatment devices.
Purevision Medical
Purevision Medical is a technology-based startup focusing on innovative ophthalmic medical devices. The company was registered in October 2020 and is committed to developing a minimally invasive treatment platform. With a founding team that combines medical and engineering expertise, Purevision Medical not only has a profound understanding of clinical needs but also possesses strong engineering and R&D capabilities. The team's unique international perspective and experience make Purevision Medical one of the few companies in China that truly owns original technology in the field of minimally invasive glaucoma treatment.
Purevision Medical is committed to creating an innovative ophthalmic minimally invasive treatment platform driven by both innovative technology and clinical needs, providing better treatment options for eye patients worldwide, enriching patient choices, and improving their quality of life.
To enter the special review process for innovative medical devices, three basic conditions must be met:
(1) The applicant, through its leading technological innovation activities, legally owns the core technology invention patent rights of the product in China, or has obtained the invention patent rights or its usage rights in China through legal transfer. The special review application time for innovative medical devices does not exceed 5 years from the patent authorization publication date; or the core technology invention patent application has been disclosed by the State Council’s patent administration department and a search report has been issued by the Patent Search and Consultation Center of the National Intellectual Property Administration, which states that the core technical solution of the product possesses novelty and inventiveness.
(II) The applicant has completed the preliminary research of the product and has a basically finalized product. The research process was genuine and controlled, and the research data is complete and traceable.
(III) The main working principle or mechanism of action of the product isFirst of its kind in China, the product performance or safety has fundamentally improved compared to similar products, and is technicallyInternational leading level, with significant clinical application value。
Purevision Medical's entry into the innovative special review channel affirms the company's outstanding achievements in the field of medical device innovation. It also highly recognizes Medpark's continuous efforts and remarkable contributions to promoting the innovative development of medical devices over a long period.
As of now, Medpark has11 ProductsInnovative products enter the "Green Channel" for innovative medical devices in China.
NextMedpark will continue to firmly adhere to the strategic route of digital leadership, innovation-driven growth, and cluster development, further enhancing industrial competitiveness. It is committed to exploring and highlighting its unique strengths, precisely meeting the needs of medical device companies in product development, technology upgrading, and achievement transformation. By continuously optimizing the innovation ecosystem, Medpark will provide higher-quality services and support for enterprises within the park, facilitating the emergence of more innovative achievements and promoting the rapid development of China's medical device industry.
