Route 92 announces US FDA 510(k) clearance for FreeClimb 54 reperfusion system


Route 92 Medical has today announced receipt of US Food and Drug Administration (FDA) 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, designed to work harmoniously as a complete endovascular thrombectomy solution to address a broad range of neurovascular interventions, according to a company press release.

“Route 92 Medical works to provide innovative endovascular thrombectomy solutions to clinicians, helping them maximise their opportunity to restore blood flow to the brain on their first attempt,” said Tony Chou, chief executive officer of Route 92. “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, predictably reach and remove stroke-causing clots during endovascular thrombectomy procedures. Route 92’s recent press release also notes that FreeClimb 54’s robust tip and shaft design facilitates use for multiple passes, and compatibility with other technologies. Additionally, the 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 (Riverside Methodist Hospital, Columbus, USA). “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 recanalisation of vessels on the first attempt.”

“The FreeClimb 54 system is a gamechanger,” added Ronald Budzik (Riverside Methodist Hospital, Columbus, USA). “It is a simple system capable of getting a larger bore aspiration catheter to distal anatomy, especially around tighter turns.”


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