FDA Clears Rapid Medical’s Drivewire, a Steerable Neurovascular Guidewire

December 22, 2020—Rapid Medical, an Israel-based company focused on the development of neurovascular devices, announced the FDA clearance of Drivewire, a guidewire with a steerable distal tip to handle complex anatomic turns. This device is named Columbus outside of the United States.

According to Rapid Medical, the Drivewire neurovascular guidewire features 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 anatomic site.

The interventionist controls the direction and shape of the guidewire’s tip while it is inside the vessel to navigate through the neuro and peripheral vasculature. This intravascular steering provides access to difficult anatomic locations, increasing the physician’s ability to treat vascular diseases with less invasive interventional approaches, stated the company.

“The development of Drivewire has been an exciting collaboration,” commented Erez Nossek, MD, in Rapid Medical’s announcement. “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. I expect this first-of-its-kind technology to benefit patients with challenging anatomies and increase the interventional treatment options available to them.” Dr. Nossek is a neurosurgeon at NYU Langone in New York, New York.