Michael Barbella, Managing Editor10.06.23
Route 92 Medical Inc. is sharing results of a first-in-human study featuring the FreeClimb 70 reperfusion system. The study, conducted across five U.S. centers and one international site, reported impressive M1 first pass effect (FPE) results, with no procedural complications, and illustrates the system's efficiency.
“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,” Route 92 Medical CEO Tony Chou said. “The results from this publication studying the FreeClimb 70 reperfusion system are a testament to our ability to develop and commercialize devices that improve upon the standard of care and raise the bar for stroke intervention.”
The FreeClimb 70 reperfusion system, which received U.S. Food and Drug Administration 510(k) clearance earlier this year, is the first fully integrated solution designed around the 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.
The study included 30 consecutive patients and showed a 61% M1 FPE, 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 12-minute median time from groin puncture to first pass. In this early clinical expierience with Tenzing, additional support or anchoring devices like stent retrievers were not needed to deliver the aspiration catheter to the target, helping 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. Minimizing guidewire use highlights the system’s ability to enhance stroke treatment while potentially reducing risks like vessel perforation and dissection.
"The FreeClimb 70 reperfusion system's performance in this study confirms its potential to enhance patient outcomes significantly,” said lead study author Fabio Settecase, M.D., of Sutter West Bay Medical Group. “Its rapid delivery, effectiveness and safety profile, combined with its efficiency, make it an exceptional advancement in stroke intervention technology."
Route 92 Medical aims to improve outcomes for patients undergoing neurovascular intervention through engineering and innovative product design. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver differentiated solutions that promote clinical success.
“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,” Route 92 Medical CEO Tony Chou said. “The results from this publication studying the FreeClimb 70 reperfusion system are a testament to our ability to develop and commercialize devices that improve upon the standard of care and raise the bar for stroke intervention.”
The FreeClimb 70 reperfusion system, which received U.S. Food and Drug Administration 510(k) clearance earlier this year, is the first fully integrated solution designed around the 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.
The study included 30 consecutive patients and showed a 61% M1 FPE, 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 12-minute median time from groin puncture to first pass. In this early clinical expierience with Tenzing, additional support or anchoring devices like stent retrievers were not needed to deliver the aspiration catheter to the target, helping 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. Minimizing guidewire use highlights the system’s ability to enhance stroke treatment while potentially reducing risks like vessel perforation and dissection.
"The FreeClimb 70 reperfusion system's performance in this study confirms its potential to enhance patient outcomes significantly,” said lead study author Fabio Settecase, M.D., of Sutter West Bay Medical Group. “Its rapid delivery, effectiveness and safety profile, combined with its efficiency, make it an exceptional advancement in stroke intervention technology."
Route 92 Medical aims to improve outcomes for patients undergoing neurovascular intervention through engineering and innovative product design. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver differentiated solutions that promote clinical success.