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Artiria Medical

Artiria receives FDA 510(k) Clearance for its deflectable guidewire for surgery

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Artiria Medical, a Vaud-based neurovascular MedTech company, announces that its real-time deflectable guidewire has been granted the 510(k) clearance by the U.S. Food and Drug Administration (FDA).



This significant milestone opens a new pathway to a more advanced and effective approach to stroke treatment and related neurovascular and peripheral conditions.


Artiria’s real-time deflectable guidewire offers the next level of control to the physicians and an improved way to navigate the complex network of cerebral arteries. The distal tip can be shaped, in real time, without removing the device from the patient. Similarly, the support profile of the wire can be adjusted along the procedure, as needed.


“We are excited about receiving the FDA clearance on a cutting-edge Swiss-made technology” said Guillaume Petit-Pierre, co-founder and CEO of Artiria Medical. ” We are looking forward to starting our clinical activities in the U.S. very soon! “. Marc Boers, co-founder and COO of Artiria shared: “Our sincere thanks go out to our dedicated team who has helped us to reach this significant milestone.”


Neurovascular interventions are often hindered by the time-consuming task of navigating through the dense maze of brain arteries. Artiria’s innovation provides a novel solution, seamlessly integrating into current clinical practice. The company next steps involve gaining clinical experience through collaboration with U.S.-based centers to demonstrate the clinical effectiveness of its product.


A revolutionary neurovascular guiding system

Artiria Medical developed a revolutionary neurovascular guiding system intended for the treatment of diseases such as stroke. Globally, one in four people over age 25 will have a stroke in their lifetime. This disease most often leads to severe disabilities and death. Currently, the standard of care is based on a minimally invasive approach, using the patient’s arteries as an access route to reach the lesion and locally deliver lifesaving treatments. However, this procedure can be very challenging, as the device navigation takes place in a dense network of tiny brain arteries.


Last year, the EPFL spin-off raised CHF 3.8 Million for its technology.


Source: press release