Route 92 Medical Gets FDA OK for FreeClimb 54 Reperfusion System

Route 92 Medical, a privately-held company specializing in neurovascular intervention, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its FreeClimb 54 reperfusion system.
 
The system is composed of the FreeClimb 54 aspiration catheter paired with a Tenzing 5 delivery catheter. The new system, according to the company, is part of a growing neurovascular device portfolio aimed at working harmoniously as a complete endovascular thrombectomy solution for a broad range of neurovascular interventions.
 
The FreeClimb 54 system can telescope through Route 92’s complementary products to help rapidly and predictably 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.
 
Further, FreeClimb 54 can be used to remove distal clots, should first-line therapies fail to completely remove the clot.
 
“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,” said Peter Pema, MD, co-director, Neurointerventional Surgery at Riverside Methodist Hospital in Columbus Ohio. “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.”
 
“It is a simple system capable of getting a larger bore aspiration catheter to distal anatomy, especially around tighter turns,” added Ronald Budzik, MD, Medical Director, Ohio Health Riverside Methodist Hospital Comprehensive Stroke Center and Neurointerventional Radiology.
 
Route 92 Medical designed its FreeClimb and HiPoint products to work together to simplify endovascular thrombectomy procedures, letting physicians select the best catheter length and size for every case. 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.
 
“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 Route 92 CEO Tony Chou, CEO. “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.”