SAN MATEO, Calif., July 31, 2023 (GLOBE NEWSWIRE) -- Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the publication of a first-in-human study featuring the FreeClimb® 70 reperfusion system in the Interventional Neuroradiology Journal. 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,” said Tony Chou, CEO of Route 92 Medical. “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 in April 2023, 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 an M1 FPE of 61%, 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. 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 Fabio Settecase, MD, MSc, FRCPC, of Sutter West Bay Medical Group, 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.”
For more information about Route 92 Medical and the FreeClimb 70 reperfusion system, visit www.route92medical.com.
About Route 92 Medical, Inc.
Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering and innovative product design. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver meaningful, differentiated solutions that promote clinical success. For more information, visit www.route92medical.com or follow the company on LinkedIn.
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Gwen Gordon
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