SmartGUIDE - Enabling a New Standard of Care Through a Smart Guidewire Device to Fight Stroke and Save Lives

Información del proyecto

SmartGUIDE

Identificador del acuerdo de subvención: 886909

DOI

10.3030/886909

Proyecto cerrado

Fecha de la firma de la CE 26 Noviembre 2019

Fecha de inicio 1 Diciembre 2019

Fecha de finalización 31 Marzo 2020

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

ARTIRIA MEDICAL SA
Switzerland

Periodic Reporting for period 1 - SmartGUIDE (SmartGUIDE - Enabling a New Standard of Care Through a Smart Guidewire Device to Fight Stroke and Save Lives)

Período documentado: 2019-12-01 hasta 2020-03-31

Resumen del contexto y de los objetivos generales del proyecto

Each year, 15 million people suffer from stroke, resulting in 5 million deaths worldwide. This disease is treated via endovascular radio-guided surgery, where the guidewire used to navigate in arteries to reach a lesion is very difficult to orient and steer. At least 5 times per surgery, the surgeon has no choice but to remove the guidewire and reshape the tip by hand, which is a poorly controlled procedure. This results in an increased risk of infection and artery puncture for the patient, longer surgery duration (by 30 minutes) and higher costs.

Artiria Medical is a Swiss spin-off from the EPFL founded in 2017 with the vision to bring disruptive minimally invasive technologies to physicians in order to decrease stroke mortality and improve the patient’s quality of life. Our first product, SmartGUIDE, is the next generation guidewire which comprises a unique remotely-shapeable tip, developed in collaboration with renowned specialists in the field of interventional neuroradiology. This patented innovation allows the surgeon to deflect in real-time, using a manipulator handle, the device head whilst navigating through brain arteries, making it easy to use with little training required.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

The formal preclinical validation study was conducted at the Bern Inselspital in large animal models (NZW rabbit) between June and December 2019. In parallel to the preclinical assessment, an in vitro study in reproduced complex aneurysm geometries silicone models was conducted. The results obtained are very promising as they show that device safety parameters are met while navigation performance is improved by a 3 times factor on average.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

Compared to the state of the art, SmartGUIDE saves 30 minutes per surgery. Saving time translates to a direct improvement of patient recovery. Scientific literature shows that during ischemic stroke procedures, 43 minutes saved led to +19% increase in full recovery cases vs. control. The full recovery rate when using SmartGUIDE is thus expected to be about 13% higher.
From a financial perspective, SmartGUIDE replaces on average 2 devices for each procedure, thus reducing the overall surgery cost by €1,400 and is fully compatible with existing endovascular devices. An average hospital doing 320 procedures per year will realise €448,000 cost savings annually.

Operating process

SmartGUIDE is the world first dynamically steerable guidewire