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FDA clearance for Tristel OPH
FDA clearance for Tristel OPH.
About this update from Tristel Plc
[{"type":"text","content":"\n\nTRISTEL plc\n(\"Tristel\" or the \"Company\")\n \nFDA clearance for Tristel OPH\n \nOphthalmic high-level disinfectant now approved for immediate sale in the US\n \nTristel plc (AIM: TSTL), the manufacturer of infection prevention products, announces that the US Food and Drug Administration (\"FDA\") has completed its review of the Company's 510(k) filing for Tristel OPH, and has granted its clearance for immediate sale. Tristel OPH is a high-level disinfectant (\"HLD\") foam for use on ophthalmic medical devices, including re-usable tonometers, pachymeters, lenses, retinal imaging probes, A-scan and B-scan biometry probes that make contact with the cornea.\n \nWith c.16 million ophthalmic procedures taking place every year in North America, the Board believes that FDA clearance has the potential to transform ophthalmic disinfection practice in the region.\n \nUntil now, the only FDA-cleared HLD method available for ophthalmic devices involves soaking in an open tray. This method is slow, given the long contact times required to be effective, and has as a result proven to be impractical to implement at point of care. In addition, the use of chemicals, such as sodium hypochlorite or hydrogen peroxide in an open tray, leads to occupational health concerns and may require costly implementation of ventilation. Prolonged exposure in a chemical soak can also lead to device damage. \n \nTo address the problems, some clinics have turned to costly single-use devices, for which there is not always an option, while others have compromised by using low-level disinfectants options, such as alcohol wipes.\n \nIn comparison, Tristel OPH has a short contact time of two minutes, is compatible with all widely used ophthalmic medical devices, is easily used at the point of care and is instantly deployable.\n \nThe Company has already established local US manufacturing with its partner Parker Laboratories, and numerous leading eye institutes in the US have already approached Tristel to become early adopters in anticipation of FDA clearance for Tristel OPH.\n \nMatt Sassone, Chief Executive Officer of Tristel, commented: \"We are delighted to receive FDA clearance for our second high level disinfectant product in the US. Tristel OPH directly addresses a long-standing unmet need in ophthalmic devi...