Title: Mistral: an innovative device for mixing and delivering gas for use in vitreoretinal surgery
Funder: Department of Health and Social Care

Abstract: Aims When retinal surgery is successful it can restore sight. If retinal surgery fails or there are complications people can become blind. Some people may need a second or third operation if there are complications. One cause of complications and failure is inaccuracy in the mixing (concentration) and delivery (pressure) of the gases that are used during surgery. Currently the concentration and pressure of these gases is done manually. The Mistral project will develop a new medical device for use in eye surgery for disorders than can result in blindness if untreated. The Mistral device will remove the need for manual control of gases used in surgery. Instead the device will mix and deliver the gases used in surgical operations. Mistral will make this critical step in the operation better controlled and more accurate &ndash; and therefore safer and more successful. Mistral will bring accuracy and precision to gas mixing and delivery, and so reduce the number of operations that go wrong or fail, In the UK around 12,000 &ndash; 15,000 patients per year develop conditions for which Mistral could be used. These people could avoid the trauma of addition surgeries, complications and blindness. Worldwide around 200,000 per year could be helped by the use of Mistral. Mistral could also make the use of the gases more efficient and so cheaper. Our estimates are that the cost of the gases themselves could be reduced by about half, which will also save the NHS money. Background to the research We have an early version of the Mistral device and we now want to make the device better and ready for clinical use. So far we have proved that the method of mixing the gas precisely, and delivering the mix at stable pressure, works, and we have identified the refinements it will need to meet UK and international regulations for medical devices. Design and methods used The current stage of the development will refine Mistral s circuits , valves, sensors and assemblies, and measure and test their performance. Our technical partners are manufacturers of specialised valves designed for use in medical devices Plymouth University Hospitals NHS Trust a global Testing House Patient and public involvement With Plymouth University Hospitals NHS Trust we will: collect feedback from patients undergoing retinal surgery record the effect on patients of surgery using existing techniques, and compare these with operations using Mistral use this information from patients to guide improvements to Mistral. Dissemination We shall share the results of this stage of the project with: clinicians, by means of articles in peer-reviewed journals commercial partners, in order to accelerate its regulatory certification and availability for clinical use in the UK and worldwide

Lay abstract: Aims When retinal surgery is successful it can restore sight. If retinal surgery fails or there are complications people can become blind. Some people may need a second or third operation if there are complications. One cause of complications and failure is inaccuracy in the mixing (concentration) and delivery (pressure) of the gases that are used during surgery. Currently the concentration and pressure of these gases is done manually. The Mistral project will develop a new medical device for use in eye surgery for disorders than can result in blindness if untreated. The Mistral device will remove the need for manual control of gases used in surgery. Instead the device will mix and deliver the gases used in surgical operations. Mistral will make this critical step in the operation better controlled and more accurate &ndash; and therefore safer and more successful. Mistral will bring accuracy and precision to gas mixing and delivery, and so reduce the number of operations that go wrong or fail, In the UK around 12,000 &ndash; 15,000 patients per year develop conditions for which Mistral could be used. These people could avoid the trauma of addition surgeries, complications and blindness. Worldwide around 200,000 per year could be helped by the use of Mistral. Mistral could also make the use of the gases more efficient and so cheaper. Our estimates are that the cost of the gases themselves could be reduced by about half, which will also save the NHS money. Background to the research We have an early version of the Mistral device and we now want to make the device better and ready for clinical use. So far we have proved that the method of mixing the gas precisely, and delivering the mix at stable pressure, works, and we have identified the refinements it will need to meet UK and international regulations for medical devices. Design and methods used The current stage of the development will refine Mistral s circuits , valves, sensors and assemblies, and measure and test their performance. Our technical partners are manufacturers of specialised valves designed for use in medical devices Plymouth University Hospitals NHS Trust a global Testing House Patient and public involvement With Plymouth University Hospitals NHS Trust we will: collect feedback from patients undergoing retinal surgery record the effect on patients of surgery using existing techniques, and compare these with operations using Mistral use this information from patients to guide improvements to Mistral. Dissemination We shall share the results of this stage of the project with: clinicians, by means of articles in peer-reviewed journals commercial partners, in order to accelerate its regulatory certification and availability for clinical use in the UK and worldwide

Research activity codes: 5.3 MEDICAL DEVICES
Health categories: EYE