Artiria Medical, a Swiss innovator in neurovascular technologies, proudly announces that its SmartGUIDE 014 deflectable guidewire, a next-generation guidewire specifically developed for neurovascular interventions, has received CE Mark certification under the European Medical Device Regulation (EU MDR).
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The SmartGUIDE 014 is engineered to support physicians in navigating the intricate and delicate blood vessels of the brain, making it an essential tool for procedures such as the treatment of ischaemic and hemorrhagic strokes. The device’s small size, 0.014 in, makes
it compatible with most of the neurovascular materials available on the market, a key advantage poised to drive rapid adoption.
“The ability to adjust and deflect SmartGUIDE’s tip dynamically in vivo and in real time not only makes it a unique technology but also expands access to challenging neurovascular targets even more efficiently”, says Dr. Jan-Karl Burkhardt, Division Head, Cerebrovascular Surgery, Hospital of the University of Pennsylvania.
The CE Mark certification, combined with FDA clearance, gives Artiria Medical access to both the European and U.S. markets. Building on excellent clinical data, Artiria Medical is now on track to launch significant commercialization, opening access to large and strategic markets. These market opportunities will be further strengthened by a growing product portfolio currently under preparation.
The CE Mark was granted after a successful review of SmartGUIDE 014’s technical documentation and clinical data, confirming compliance with strict safety and performance standards. This reflects Artiria Medical’s commitment to quality and patient care.
