Artiria Medical, a Swiss 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).
Borex, Switzerland , Artiria Medical, a Swiss neurovascular company, is delighted to announce 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.
RELATED: iHealthScreen receives FDA 510(k) for AI-enabled eye screening system
About Artiria Medical
Artiria Medical, is a MedTech company spun-out from the Swiss Federal Institute of Technology in Lausanne (EPFL). Incorporated in 2019, Artiria has a strong focus on innovative neurovascular interventions. Its mission is to revolutionize stroke treatment with cutting-edge technology to enhance patient care.
For further information, please contact:
Artiria Medical SA
