Route 92 Medical announced it received FDA 510(k) clearance for its FreeClimb 54 reperfusion system.
The FreeClimb54 system uses an aspiration catheter of the same name paired with a Tenzing 5 delivery catheter. The new system is part of the company’s growing portfolio of neurovascular devices designed to work as complete endovascular thrombectomy solutions for neurovascular interventions.
Related: ClearPoint Neuro wins FDA clearance for neuro laser therapy accessory
“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,” CEO Tony Chou said. “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.”
Route 92 Medical’s FreeClimb 54 system can telescope through the company’s complementary products to allow physicians to rapidly and predictably reach and remove stroke-causing clots during endovascular thrombectomy procedures. The tip and shaft design allows for its use in multiple passes and compatibility with other technologies. The system can also be used to remove distal clots when first-line therapies fail to completely remove them.
“The launch of the FreeClimb 54 reperfusion system continues Route 92 Medical’s progressive and complete approach to stroke care,” Dr. Peter Pema, co-director of Neurointerventional Surgery at Riverside Methodist Hospital in Columbus, Ohio, said. “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.”
