Intracranial aneurysms (IA’s) are a balloon like dilation on the arterial wall of the intracranial vasculature system. Under haemodynamic pressure, IA’s can grow and rupture leading to a subarachnoid haemorrhage (SAH). Each year ~51,000 EU citizens suffer a SAH, of whom 40% will die and a further 40% will suffer severe neurological disabilities requiring long-term social care. However, SAH’s are entirely avoidable through early intervention. Oxford Endovascular Ltd is developing a cure for brain aneurysms. The Project Team combines >100 years’ experience in the Med-tech sector, with >30 years direct clinical experience, and internationally renowned technical expertise in the development of novel endovascular devices using origami design principles.
Existing aneurysm treatment options include surgical clipping, an invasive procedure that, whilst delivering excellent long-term resolution, is an invasive, risky and expensive procedure with long patient recovery periods; and endovascular coiling, a minimally invasive procedure that, whilst lower risk, less expensive and with quicker patient recovery, delivers poorer long-term resolution. Neither techniques heal & remove the aneurysm and thus have the potential long-term symptoms and re-bleeding.
Flow diverters (FD’s) are a newer but established endovascular device that divert blood flow away from the aneurysm, thus eliminating the risk of growth/rupture and enabling natural healing. Whilst a promising excellent long-term resolution at lower risk and cost, existing FD’s have limitations inherent to their braided mesh design have uncontrolled and non-uniform radial forces, resulting in landing in the wrong position, poor opening and vessel apposition (areas prone to clot formation & creating stroke risk), variable porosity (poor flow dynamics) & device coning (causing migration).
OxiFlow is made from a shape memory nickel-titanium alloy and integrates origami design principles. The design combines an inner frame to address the placement and opening issues, with and outer sleeve to deal with the flow diversions and healing. The OxiFlow design enables optimum and uniform radial forces thereby overcoming the limitations of existing FDs. Furthermore, OxiFlow utilises an innovative delivery system that enables improved end user (doctor) control making the device easier and safer to place.
OxiFlow seeks to evaluate the safety and performance of the OxiFlow device through a 10- patient First-in-Human (FIH) clinical study. Project activities include device design freeze; transfer to and validation of pilot scale manufacture; pre-clinical verification and validation testing; GLP animal study; FIH study design and risk assessment; regulatory & ethical committee approvals; & FIH study implementation.
