Descrizione del progetto
Design innovativo per un deviatore di flusso per l'aneurisma cerebrale
Gli aneurismi intercranici, la cui potenziale rottura porta a tassi di mortalità e disabilità altrettanto elevati, sono difficili da trattare a causa di vasi stretti e complessi. Due metodi chirurgici di gestione offrono un rischio elevato per il paziente o risultati scadenti a lungo termine. Una soluzione alternativa è rappresentata dai deviatori di flusso (DF) endovascolare, che riducono il rischio di rottura drenando l’aneurisma del sangue. Ad oggi, tuttavia, il loro design a maglia ha presentato problemi di posizionamento e stabilità. Il progetto OXIFLOW risolve questo problema riprogettando i dispositivi DF, sulla base di tecniche origami e introducendo un materiale a memoria di forma. OxiFlow offre anche un sistema di rilascio con un migliore controllo del filo guida, particolarmente adatto per vasi cerebrali sottili e intricati.
Obiettivo
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.
Campo scientifico
Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SMEInst-2018-2020-2
Meccanismo di finanziamento
SME-2 - SME instrument phase 2Coordinatore
OX4 2HN Oxford
Regno Unito
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