Project description
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.
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
Programme(s)
Funding Scheme
SME-2 - SME instrument phase 2Coordinator
OX4 2HN Oxford
United Kingdom
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.