Artiria Medical has announced 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 (MDR).
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 employed in the treatment of ischaemic and haemorrhagic strokes, as stated in an Artiria press release.
The device’s small size (0.014 inches) makes it compatible with most of the neurovascular materials available on the market, which the company believes represents a key advantage that is set 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,” commented Jan-Karl Burkhardt (University of Pennsylvania, Philadelphia, USA).
This CE-mark certification—combined with prior US Food and Drug Administration (FDA) clearance—gives Artiria access to both European and US markets.
Building on “excellent” clinical data, the company notes that it is now on track to launch significant commercialisation, opening access to large and strategic markets—and 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, Artiria’s release further states.
