Rapid Medical has announced US Food and Drug Administration (FDA) clearance of its Drivewire 35 device—the “first” 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 the ongoing Society of NeuroInterventional Surgery (SNIS) annual meeting (20–24 July, Seattle, USA).
Jeremy Rempel (University of Alberta Hospital, Edmonton, Canada) performed the first clinical cases worldwide, including successfully navigating catheters to treat an intracranial occlusion without crossing the clot.
“In stroke, every minute matters,” said Rempel. “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.”
Drivewire 35 is described by Rapid Medical as 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 helps physicians select vessels, navigate challenging anatomy, bypass the ledge effect, and reach the treatment site with fewer nested devices, the company adds.
“The nearly 5,000 Drivewire 24 cases demonstrate the growing role of steerable access,” stated James Romero, president of the Americas at Rapid Medical. “Drivewire 35 brings that same active control to a larger platform, helping physicians navigate complex anatomy across neurovascular and peripheral vascular procedures.”
Drivewire 35 is the third steerable guidewire in Rapid Medical’s expanding portfolio, according to the company.
