FDA OKs Rapid Medical’s Steerable Neurovascular Guidewire

Rapid Medical, a company focused on the development of the first class of responsive, adjustable neurovascular devices, announces the FDA clearance of DRIVEWIRE, a novel guidewire with a steerable distal tip that handles complex anatomical turns with ease. This device is named Columbus outside of the United States.
 
With DRIVEWIRE, physicians control the direction and shape of the guidewire’s tip while it is inside the vessel, precisely navigating the neuro and peripheral vasculature. This intravascular steering provides access to difficult anatomical locations, increasing the physician’s ability to treat vascular diseases with less invasive interventional approaches.
 
Guidewires are key components for treating intravascular diseases such as ischemic and hemorrhagic strokes. Currently, physicians do not have direct control over the guidewire tip and often remove the guidewire several times to reshape it before reaching the desired location. DRIVEWIRE is the first neurovascular guidewire with a controllable distal end that can change course and shape on-demand for more precise navigation. This enables physicians to select the most efficient and safest route to the anatomical site.
 
“The development of DRIVEWIRE has been an exciting collaboration. I can now easily navigate through complex anatomies by varying the shape of the wire tip inside the vessel, something that can’t be performed with the current neurovascular guidewires,” commented Dr. Erez Nossek, a neurosurgeon at NYU Langone in New York, N.Y. “I expect this first-of-its-kind technology to benefit patients with challenging anatomies and increase the interventional treatment options available to them.”