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Ramiro Ribeiro, Mark S Humayun, Rick Purvis, Evan Tsang, Fukang Jiang, Jason Shih, Gregory Harbers, Atoosa Lotfi, Lukas C Scheibler, Sean Caffey; Evaluation of the Performance, Biocompatibility and Safety of a New Posterior MicroPump Drug Delivery System. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):157.
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© ARVO (1962-2015); The Authors (2016-present)
Demonstrate the performance, biocompatibility and safety profile of the next generation Replenish Posterior MicroPump (PMP).
The PMP was iterated to a new design to improve the robustness of the package, reliability, manufacturability and usability. Performance of the PMP was demonstrated in a series on bench tests. Ten fully assembled pumps were filled with ranibizumab and kept at 37°C. Each pump was wirelessly commanded to deliver one dose every 30 days for a period of 6 months. In addition, four pumps were tested for seven years of cycling pumping in an acellerated life test. Biocompatibility and safety were evaluated in a preclinical animal study in which 6 canines received bilateral ocular implantation. Each animal received the implantation of the PMP in the study eye and the implant of a medical titanium control article in the fellow eye per ISO 10993-6. The control articles had similar dimensions as the PMP without the presence of the intraocular cannula. Clinical ophthalmic exams were done at baseline and monthly post-operatively. Animals were euthanized at 3 (n=3) and 6 (n=3) months of follow-up and the globes submitted for histopathology studies. All experiments were performed in compliance with the ARVO Statement on the Use of Animals Care and Visual Research
All ten pumps functioned as designed and were able to deliver the doses accurately within the specification range volume. The additional four pumps were able to keep functioning over the seven year of life cycle. In preclinical testings, all animals presented with standard healing process after the surgical implantation. There were no cases of endophthalmitis or retinal detachment. No clinical difference was noted in the eyes that received the implantation of the PMP versus the titanium control article. Histological evaluations were considered a typical host response to a surgical procedure and implantation of an inert medical device without difference between the globes that received the PMP and the control article.
The next generation Replenish PMP demonstrated the proper function at body temperature for a period of up to 6 months on the bench, with cycle life of at least 7 years on the bench. The PMP was also considered safe and biocompatible when implanted for a period of up to 6 months in an animal model.
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