Route 92 Medical Announces FDA 510(k) Clearance for FreeClimb 54 Reperfusion System

SAN MATEO, Calif., April 30, 2024 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced receipt of 510(k) clearance for the FreeClimb^® 54 reperfusion system, comprised of the FreeClimb 54 aspiration catheter paired with a Tenzing^® 5 delivery catheter. This new system is part of a growing portfolio of neurovascular devices from Route 92 Medical designed to work harmoniously as a complete endovascular thrombectomy solution to address a broad range of neurovascular interventions.

“Route 92 Medical works to provide innovative endovascular thrombectomy solutions to clinicians, helping them maximize their opportunity to restore blood flow to the brain on their first attempt,” said Tony Chou, CEO of Route 92 Medical. “The FreeClimb 54 reperfusion system is an essential addition to our product portfolio, enabling clinicians to use our products to address a wider range of patient needs.”

The FreeClimb 54 system can telescope through the company’s complementary products allowing physicians to rapidly and predictably reach and remove stroke-causing clots during endovascular thrombectomy procedures. Its robust tip and shaft design facilitates use for multiple passes and compatibility with other technologies. Additionally, the FreeClimb 54 system may be used to remove distal clots when first-line therapies fail to completely remove the clot.

“The launch of the FreeClimb 54 reperfusion system continues Route 92 Medical’s progressive and complete approach to stroke care,” stated Peter Pema, MD, Co-Director, Neurointerventional Surgery at Riverside Methodist Hospital in Columbus Ohio. “This system combines the unparalleled effectiveness and safety of their Tenzing delivery system with an aspiration catheter that can reach far into the cerebral circulation beyond the proximal branch vessels. Thus, the size of the FreeClimb 54 system offers clear advantages to clinicians looking to achieve rapid, safe recanalization of vessels on the first attempt.”

“The FreeClimb 54 system is a game changer,” said Ronald Budzik, MD, Medical Director, Ohio Health Riverside Methodist Hospital Comprehensive Stroke Center and Neurointerventional Radiology. “It is a simple system capable of getting a larger bore aspiration catheter to distal anatomy, especially around tighter turns.”

Route 92 Medical has designed its FreeClimb and HiPoint^® families of products to work together to simplify endovascular thrombectomy procedures, enabling physicians to select the optimal length and size of catheter for every case. The FreeClimb 54 complements the FreeClimb 70 reperfusion system, as well as the company’s FreeClimb 88, HiPoint 70 and HiPoint 88 access systems, all of which are powered by custom-sized Tenzing delivery catheters. The navigational capabilities of Tenzing delivery catheters allow rapid and predictable delivery to the target lesion, reducing or eliminating the need for a microcatheter, and ultimately improving procedural efficiency.

For more information about other Route 92 Medical-developed neurovascular interventional devices, visit www.route92medical.com/products.

About Route 92 Medical, Inc.

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering and innovative product design. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver meaningful, differentiated solutions that promote clinical success. For more information, visit www.r92m.com or follow the company on LinkedIn.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ba73be39-5e25-4d5e-abb9-c058b16990c8

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