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

Project Information

SmartGUIDE

Grant agreement ID: 886909

DOI

10.3030/886909

Project closed

EC signature date 26 November 2019

Start date 1 December 2019

End date 31 March 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

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)

Reporting period: 2019-12-01 to 2020-03-31

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

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