Route 92 Medical has today announced the publication of a retrospective, first-in-human study featuring its FreeClimb 70 reperfusion system in the journal Interventional Neuroradiology. The study, conducted across five US centres and one international site, reports “impressive” M1 first-pass effect (FPE) results, with no procedural complications, and illustrates the system’s efficiency, as per a company press release.
“The FreeClimb 70 reperfusion system’s performance in this study confirms its potential to enhance patient outcomes significantly,” said Fabio Settecase (Sutter West Bay Medical Group, San Francisco, USA), the lead author on the study. “Its rapid delivery, effectiveness and safety profile, combined with its efficiency, make it an exceptional advancement in stroke intervention technology.”
The FreeClimb 70 reperfusion system, which received US Food and Drug Administration 510(k) clearance in April 2023, is the first fully integrated solution designed around Route 92’s Tenzing 7 delivery catheter. The system’s advanced design eliminates the ‘ledge effect’ commonly found in large-bore catheters, and offers “superior navigation and predictable access” to occluded distal vessels—typically without the need for a guidewire—according to the company.
The newly published study included 30 consecutive patients and showed an M1 FPE of 61%—which Route 92 claims is one of the highest endovascular thrombectomy FPE rates ever published. The FreeClimb 70 reperfusion system demonstrated a 100% success rate in navigating to the occlusion site, with a median time of only 12 minutes from groin puncture to first pass.
In this early clinical experience with Tenzing, additional support or anchoring devices like stent retrievers were not needed to deliver the aspiration catheter to the target, helping to reduce procedure costs. Notably, 70% of cases did not require a leading guidewire to advance the Tenzing to the occlusion. Typically, with Tenzing use, there is no guidewire delivery past the occlusion to fragile distal anatomy. Minimising guidewire use highlights the system’s ability to enhance stroke treatment while potentially reducing risks like vessel perforation and dissection, the company’s recent release states.
“Route 92 Medical is focused on refining stroke intervention with a suite of solutions designed to simplify endovascular thrombectomy procedures and ultimately improve patient outcomes,” said Tony Chou, CEO of Route 92. “The results from this publication studying the FreeClimb 70 reperfusion system are a testament to our ability to develop and commercialise devices that improve upon the standard of care, and raise the bar for stroke intervention.”