Rapid Medical Gets FDA OK for Steerable Neurovascular Guidewire

Israel-based Rapid Medical has been granted 510(k) clearance by the FDA for Drivewire, a steerable guidewire that can make complex turns during neurovascular surgeries.

Guidewires are frequently used in treating strokes, but physicians often must remove and reshape the tips. The Drivewire device enables physicians to adjust the direction and shape of the guidewire’s tip while it is still inside the vessel.  

The device, which is named “Columbus” outside the U.S., is “the world’s first steerable neurovascular guidewire,” Rapid Medical said.