The intricate and dense network of brain arteries often complicates neurovascular interventions, making it a time-consuming task for neurosurgeons to navigate these pathways with a wire. The wire, only a third of a millimeter in diameter, is inserted through the femoral artery and is used to reach blocked blood vessels in the brain. When a change in direction is needed, surgeons typically need to remove and reinsert the instrument, which extends operation times and heightens the risk of complications. Now, a new real-time deflectable guidewire offers an improved way to navigate these complex cerebral arteries, offering physicians enhanced control. The device's distal tip can be reshaped in real time without removal from the patient, and the wire's support profile can be adjusted as required during the procedure.

Artiria Medical (Canton of Vaud, Switzerland) has developed a wire with a steerable tip that simplifies the process for neurosurgeons to navigate the intricate network of brain arteries and reach the source of strokes. Used in conjunction with clot-dissolving medications, this surgical method, enhanced by real-time X-ray visualization of the instruments, enables mechanical clot extraction. The wire acts as a guide for other necessary surgical instruments to be inserted and seamlessly integrates with existing procedures.

The device includes an additional button on the handle that, when pressed, bends the tip. A tiny pull wire relays the slight mechanical force resulting from pressing the button along the instrument's structure to its 2-centimeter-long deflectable tip. The tip is reinforced on the side connected to the pull wire, and the other side is engineered to easily follow the movement. Despite its simple appearance, manufacturing the device’s microscopic-scale components was a notable feat of engineering. When tested on 3D-printed, clear-silicone models of cerebral arteries, the system demonstrated no significant differences for neurosurgeons.

The U.S. Food and Drug Administration (FDA) has granted Artiria’s real-time deflectable guidewire a 510(k) clearance, paving the way for a more sophisticated and effective approach to treating strokes and related neurovascular and peripheral conditions. The team is also investigating other potential uses for this technology, such as utilizing the wire to reduce spasms seen during hemorrhaging strokes by targeting a specific artery with flexible thin-film electrodes.

“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!,” added Marc Boers, co-founder and COO of Artiria “Our sincere thanks go out to our dedicated team who has helped us to reach this significant milestone.” 

http://m.allmycbs.com/en/index.asp