Artiria Medical obtains CE Mark for its deflectable guidewire

Geneva-based Artiria Medical has secured CE Mark certification under the European Medical Device Regulation (EU MDR) for SmartGUIDE 014, its next-generation deflectable guidewire engineered for neurovascular procedures. The approval complements the company’s existing FDA clearance, granting access to both European and U.S. markets and marking a major step in Artiria’s commercialization roadmap.

SmartGUIDE 014 is designed to help physicians navigate the narrow and highly tortuous blood vessels of the brain during interventions for ischemic and hemorrhagic stroke, as well as aneurysm treatments. With a diameter of 0.014 inches, the device is compatible with most neurovascular systems currently used in clinical settings, facilitating seamless integration into existing workflows.

A key feature of the technology is its articulating distal tip, which physicians can deflect and adjust dynamically in vivo. This capability supports safer and more efficient access to challenging neurovascular targets. “The ability to adjust and deflect SmartGUIDE’s tip dynamically in real time not only makes it unique, but also expands access to difficult neurovascular anatomy even more efficiently,” said Dr. Jan-Karl Burkhardt, Division Head of Cerebrovascular Surgery at the Hospital of the University of Pennsylvania.

Clinical rollout and broader commercialization

According to the company, the CE Mark approval follows a rigorous assessment of SmartGUIDE 014’s technical documentation and clinical data, confirming compliance with EU MDR’s stringent safety and performance requirements. The certification supports Artiria Medical’s plan to accelerate commercialization efforts and expand clinical availability across Europe and the United States.

The regulatory milestone comes amid growing recognition of Artiria Medical within Western Switzerland’s life sciences ecosystem. Earlier this year, the company was awarded the Best Startup Award at BioInnovation Day 2025 in Geneva for its robotic neurovascular platform designed to improve precision and accessibility in stroke interventions.

Headquartered in Geneva with activities at the EPFL Innovation Park and the Wyss Center, Artiria Medical develops minimally invasive technologies for the treatment of ischemic and hemorrhagic stroke, conditions that remain among the leading causes of disability and mortality worldwide.