Rapid Medical Announces FDA Clearance of DRIVEWIRE™ 35 and First Stroke Cases

Rapid Medical Announces FDA Clearance of DRIVEWIRE™ 35 and First Stroke Cases

First steerable 0.035-inch guidewire combines controlled tip deflection and distal support to accelerate catheter access; builds on nearly 5,000 DRIVEWIRE™ 24 cases

Rapid Medical™, a leading developer of advanced stroke treatment devices, today announced U.S. Food and Drug Administration clearance of DRIVEWIRE™ 35, 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 Society of NeuroInterventional Surgery’s (SNIS) 23rd Annual Meeting & Fellows Course.

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DRIVEWIRE™ 35 uses controlled tip deflection to shape the wire inside the vessel and add active steering to compatible catheters—helping physicians navigate complex anatomy and streamline access to the treatment site.

Jeremy Rempel, MD, of the University of Alberta Hospital in 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 Dr. 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 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 nearly 5,000 DRIVEWIRE 24 cases demonstrate the growing role of steerable access,” said 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.

About Rapid Medical
Rapid Medical expands what’s possible in neurovascular treatment by pioneering advanced interventional devices that treat ischemic and hemorrhagic stroke. Utilizing proprietary manufacturing techniques, Rapid Medical’s products are remotely adjustable and fully visible. This enables physicians to respond in real-time to the anatomy and tailor their approach to each patient for better procedural outcomes. Product families include TIGERTRIEVER™, COMANECI™, and DRIVEWIRE™. Not all products are available in all geographies. More information is available at www.rapid-medical.com.

Ronen Eckhouse
+972-72-2503331
ronen@rapid-medical.com

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