SEATTLE & YOKNEAM, Israel, July 21, 2026
Rapid Medical announced U.S. Food and Drug Administration (FDA) clearance of DRIVEWIRE™ 35, the first steerable 0.035-inch guidewire designed to improve catheter navigation during stroke and other intravascular procedures. The company also reported the successful completion of the first clinical stroke cases using the new device. Building on the experience of nearly 5,000 DRIVEWIRE™ 24 procedures, the latest addition expands Rapid Medical’s steerable guidewire portfolio by providing physicians with enhanced control for navigating complex vascular anatomy, reducing procedural complexity, and accelerating access to treatment sites.
FDA Clears First Steerable 0.035-Inch Guidewire
DRIVEWIRE™ 35 is designed to provide active steering capability by allowing physicians to shape and deflect the guidewire inside the blood vessel. This enables compatible catheters to be precisely directed through challenging vascular anatomy without relying on multiple nested devices. According to Rapid Medical, the technology helps physicians bypass the “ledge effect,” improve vessel selection, and reach target lesions more efficiently during neurovascular and peripheral vascular interventions. The FDA clearance was announced during the Society of NeuroInterventional Surgery (SNIS) 23rd Annual Meeting & Fellows Course.
First Stroke Procedures Demonstrate Clinical Utility
The first clinical procedures using DRIVEWIRE™ 35 were performed by Dr. Jeremy Rempel at the University of Alberta Hospital in Edmonton, Canada. During the initial stroke interventions, the device successfully guided catheters to intracranial occlusions without crossing the clot, an approach that may reduce procedural risks while improving efficiency. Physicians highlighted the guidewire’s ability to reshape within the vessel, enabling precise catheter steering around difficult anatomy and potentially reducing the need for additional support devices during mechanical thrombectomy procedures.
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Expanding Rapid Medical’s Neurovascular Portfolio
Rapid Medical stated that DRIVEWIRE™ 35 represents the third steerable guidewire within its growing neurovascular product portfolio. The company believes the device builds upon the success of DRIVEWIRE™ 24, which has already been used in nearly 5,000 procedures worldwide. By extending active steering technology to larger guidewire platforms, Rapid Medical aims to improve physician control across a broader range of neurovascular and peripheral vascular procedures while supporting faster access to treatment sites in time-critical conditions such as acute ischemic stroke.
Source: Rapid Medical press release
