Founded at the EPFL, Artiria Medical developed a real-time deflectable guidewire to allow neurosurgeons to safely navigate brain arteries to improve the treatment of strokes. The receipt of the 510(k) clearance by the U.S. Food and Drug Administration (FDA) is significant for the startup to market the device in the U.S.
An estimated 12 million people worldwide suffer from Stroke and its associated deaths or disabilities annually. Currently, the best remedy for stroke patients is based on minimally invasive X-ray-guided interventions. However, this procedure can be very challenging as the access takes place in a dense network of tiny brain arteries with old-fashioned devices. Furthermore, neurovascular interventions are often hindered by the time-consuming task of navigating the brain arteries.
Swiss neurovascular MedTech company Artiria Medical has developed a deflectable guidewire that gives physicians better control 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. The novel solution can be seamlessly integrated into current clinical practice.
The medical device has been granted the 510(k) clearance by the U.S. Food and Drug Administration (FDA), to commercialise the product in the U.S. As part of the next steps, the company plans to further gain clinical experience through collaboration with U.S.-based centers to demonstrate the clinical effectiveness of its product.
“We are excited about receiving the FDA clearance on cutting-edge Swiss-made technology. We are looking forward to starting our clinical activities in the U.S. very soon”, said Guillaume Petit-Pierre, co-founder and CEO of Artiria Medical.
(Press release/RAN)
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