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

Informazioni relative al progetto

SmartGUIDE

ID dell’accordo di sovvenzione: 886909

DOI

10.3030/886909

Progetto chiuso

Data della firma CE 26 Novembre 2019

Data di avvio 1 Dicembre 2019

Data di completamento 31 Marzo 2020

Finanziato da

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Costo totale

€ 71 429,00

Contributo UE

€ 50 000,00

Coordinato da

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)

Periodo di rendicontazione: 2019-12-01 al 2020-03-31

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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