Product Description
HPF10 is high purity perfluorodecalin, sterile and apyrogenic, packaged in prefilled 10 ml glass syringe with Luer Lock, to be used intraoperatively to defold and stabilize the detached retina. The product allows a safe delivery of laser energy and a reduced number of bubbles.
HPF10 is the most controlled perfluorodecalin on the market. Chemical tests of Nuclear Magnetic Resonance (NMR), Fourier Transform Infrared Spectroscopy (FT-IR) and Gas Chromatography (GC) are performed to ensure its safety. The Hvalue is less than 10 ppm and the perfluorooctanoic acid (PFOA) is absent.
Biological tests of cytotoxicity by direct contact according to ISO 10993-5 are also performed on BALB 3T3 and ARPE-19 cells.
To increase safety, HPF10 was also tested for cytotoxicity in an innovative ex-vivo human retina model. The content of endotoxins is less than 0.5 EU/ml.
HPF10 is a product tested for cytotoxicity on ARPE-19 and BALB 3T3 cells, whose results are shown on the confirmation of use labels inside the package, for a correct information to surgeon and an increased safety for the patient.
