Route 92 Medical’s FreeClimb 54 Reperfusion System Cleared by FDA

April 30, 2024—Route 92 Medical, Inc. announced receipt of 510(k) clearance for the FreeClimb 54 reperfusion system, which includes the FreeClimb 54 aspiration catheter and the Tenzing 5 delivery catheter. This new system is part of the company’s portfolio of neurovascular devices for endovascular thrombectomy.

According to Route 92 Medical, the FreeClimb 54 system can telescope through the company’s complementary products to allow physicians to reach and remove stroke-causing clots during endovascular thrombectomy procedures.

Its 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, noted the company.

“The launch of the FreeClimb 54 reperfusion system continues Route 92 Medical’s progressive and complete approach to stroke care,” commented Peter Pema, MD, in the company’s press release.

Dr. Pema, Co-Director of Neurointerventional Surgery at Riverside Methodist Hospital in Columbus Ohio, continued, “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.”

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