Project description DEENESFRITPL Innovative design for brain aneurysm flow diverter Intercranial aneurysms, whose potential rupture carries equally high death and disability rates, are difficult to treat due to narrow and complex vessels. Two surgical methods of management offer either high risk to the patient or poorer long-term results. An alternative solution is endovascular flow diverters (FDs), which lower the risk of rupture by draining the aneurysm of blood. So far, however, their mesh design has presented problems with placement and stability. The OXIFLOW project addresses this issue by redesigning FD devices, based on origami techniques, and introducing a shape memory material. OxiFlow also offers a delivery system with better guidewire control, uniquely suited for thin and intricate brain vessels. Show the project objective Hide the project objective Objective Each year ~51,000 EU citizens suffer a subarachnoid haemorrhage (SAH) resulting from the rupture of an intracranial aneurysm (IA), of whom 40% will die and 40% will suffer severe disabilities. However, SAH’s are entirely avoidable through treatment of ‘at risk’ unruptured IAs. Existing treatment options include: surgical clipping, an invasive, risky and expensive procedure but delivering excellent long-term resolution; and endovascular coiling, a cheaper and lower risk minimally invasive procedure but delivering poorer long-term resolution. Flow diverters (FDs) are an emerging endovascular device that divert blood flow away from the aneurysm thereby enabling natural healing. Whilst offering the potential of excellent long-term resolution at low risk and cost, existing FDs have failed to live up to expectations, reporting performance inferior to coiling. Limitations of existing FD’s are inherent to their mesh design that causes weak and non-uniform radial forces resulting in poor vessel apposition, variable porosity and device coning. Existing delivery systems also restrict use due to extension of the central guidewire during delivery.OxiFlow is a unique FD design based on origami principles and made from a shape memory Nitinol material. The innovative design enables optimum and uniform radial forces thereby overcoming the limitations of existing FDs. Furthermore, OxiFlow utilises a novel delivery system enabling complete user control of the central guidewire extension and thus use in small and tortuous vessels. OXIFLOW will evaluate safety and performance of the OxiFlow device through a 10-patient First-in-Man (FIM) study. Project activities include: device design freeze, transfer to pilot scale manufacture, pre-clinical testing; regulatory and ethical approvals; and FIM study implementation. The addressable EU & US market for OxiFlow is estimated at €463M. OE target €40.02M business growth over a 5-year period generating €73.56M cumulative revenues. Fields of science medical and health sciencesclinical medicineangiologyvascular diseases Programme(s) H2020-EU.2.3. - INDUSTRIAL LEADERSHIP - Innovation In SMEs Main Programme H2020-EU.3. - PRIORITY 'Societal challenges H2020-EU.2.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies Topic(s) EIC-SMEInst-2018-2020 - SME instrument Call for proposal H2020-EIC-SMEInst-2018-2020 See other projects for this call Sub call H2020-SMEInst-2018-2020-2 Funding Scheme SME-2 - SME instrument phase 2 Coordinator OXFORD ENDOVASCULAR LIMITED Net EU contribution € 2 962 979,95 Address 9400, garsington road, oxford OX4 2HN Oxford United Kingdom See on map Region South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 1 269 848,55
