You will be responsible for managing and adapting the quality system to meet the various standards required for international commercialization (ISO 13485, MDR 2017/745, MDSAP, FDA 21 CFR 820...), as well as preparing the necessary documentation for registrations outside Europe...
Primary angle-closure glaucoma (PACG) represents a significant cause of blindness, affecting more than 17 million people worldwide. Moreover, the currently available treatment options for the management PACG remain relatively limited. The cilioscleral inter-positioning device is a novel minimally invasive implant designed to increase uveoscleral outflow without entering the chamber. This unique approach to lower IOP represents a new, efficient, and safe surgical option to reduce intraocular pressure for patients with PACG.
At the World Glaucoma Congress (WGC) in Rome, Italy this summer, Ciliatech presented preliminary results of the second 2-year postoperative clinical trial (SAFARI Ⅱ) on its Cilioscleral Interposition Device (CID).
Glaucoma is a group of progressive, neurodegenerative eye diseases associated with irreversible optic neuropathy followed by visual-field impairment. Epidemiological estimates suggest that the most common form,
Results from second CID (Cilio-scleral Interposition Device) study confirm sustained decrease in intraocular pressure (IOP), while preserving anterior chamber of eye
Ciliatech reports positive clinical results on novel glaucoma implant, CID, in 24-month post-operative
follow-up. Data support sustained safety and performance of first generation glaucoma implant CID (Cilio-scleral Interpositioning Device)...