FDA Clears Rapid Medical’s Drivewire 35 Steerable Guidewire for Stroke and Other Intravascular Procedures

July 21, 2026—Rapid Medical announced FDA clearance of its Drivewire 35, which is a steerable 0.035-inch guidewire designed to help physicians reach the treatment site quickly and precisely during stroke and other intravascular procedures.

The clearance was announced at SNIS 2026, the Society of NeuroInterventional Surgery’s 23rd annual meeting.

According to the company, Drivewire 35 is a shapeable wire that adds active steering to compatible catheters. By deflecting and reshaping the wire inside the vessel, physicians can articulate the catheter tip and direct it through complex anatomy—effectively turning a conventional catheter into a steerable system.

This control is intended to help physicians select vessels, navigate challenging anatomy, bypass the ledge effect, and reach the treatment site with fewer nested devices, stated Rapid Medical.

The company advised that the first clinical cases worldwide—including successfully navigating catheters to treat an intracranial occlusion without crossing the clot—were performed by Jeremy Rempel, MD, of the University of Alberta Hospital in Edmonton, Canada.

“In stroke, every minute matters,” commented Dr. Rempel in the Rapid Medical press release. “Drivewire 35 lets me shape the wire inside the vessel and precisely direct the catheter toward the clot without pushing the wire through it. Its steering and support help me navigate around vessel edges, bypass the ledge effect, and potentially reduce the need for additional devices. This can simplify access and save valuable time.”