Regulatory

Rapid Medical Expands Into Europe With MDR Approval of DRIVEWIRE 24

Clinical performance and strong physician demand drive swift uptake and global authorization of next-generation access technology.

By: Michael Barbella

Managing Editor

Rapid Medical has earned CE Mark under the European Medical Device Regulation (MDR) for its DRIVEWIRE 24 steerable guidewire, which has been used in more than 1,000 neurovascular procedures in North America during a limited commercial launch beginning earlier this year.

“In my experience, the wire provides a unique combination of precision and support that simply hasn’t been possible with conventional technologies,” stated Dr. Erez Nossek, a neurosurgeon at NYU Langone in New York, N.Y. “It has become a reliable tool that allows us to approach any anatomy with greater efficiency and less time.”

As the first steerable 0.024-inch guidewire, DRIVEWIRE has quickly become a go-to technology in ischemic stroke, aneurysms, and other complex neurovascular conditions. With its mechanically adjustable tip, physicians can shape and steer the wire in real time—enabling faster, more reliable access to distal vessels, minimizing wire exchanges, and providing robust catheter support. In a multicenter North American analysis of 176 cases, the device successfully reached the target site in 94% of procedures with no device-related complications.

European clinicians are now preparing for adoption. After receiving training on the product, Dr. Hozan Radhi, an interventionalist at Örebro University Hospital in Örebro, Sweden, commented, “It’s clear this technology can expedite our cases exponentially. The ability to control the tip in real time opens new options for access, precision, and support. I’m eager to integrate it into my daily practice and believe it will significantly change how we approach everyday cases.”

Rapid Medical develops advanced interventional devices that treat ischemic and hemorrhagic stroke. Using proprietary manufacturing techniques, the firm’s products are remotely adjustable and fully visible, enabling physicians to respond in real time to the anatomy and tailor the approach to every patient for better procedural outcomes. TIGERTRIEVER 13, 17, and 21; COMANECI; COLUMBUS/DRIVEWIRE 14; and DRIVEWIRE 24 are CE marked and cleared by the U.S. Food and Drug Administration. TIGERTRIEVER XL and 25 are also CE marked.

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