Route 92 Medical Receives the First FDA Clearance for a Complete Stroke Treatment System

The FreeClimb 70 Reperfusion System, powered by the Tenzing 7 delivery catheter, enables neurointerventionalists to address critical unmet needs in ischemic stroke treatment

SAN MATEO, Calif., April 24, 2023 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced receipt of 510(k) clearance for the FreeClimb™ 70 Reperfusion System which includes a FreeClimb 70 Aspiration Catheter along with a Tenzing® 7 Delivery Catheter. The FreeClimb 70 Reperfusion System enables physicians to treat patients experiencing an acute ischemic stroke by removing clots rapidly and safely. This innovative, first-to-market system is designed to work together harmoniously for superior deliverability and high procedural efficiency, making it a more refined bi-axial approach for restoring blood flow to the brain during endovascular thrombectomy procedures.

“In our initial experience with FreeClimb 70 and Tenzing 7, the system easily delivered to the target occlusion allowing rapid, effective and safe reperfusion,” stated James Caldwell, MD, an early user of the system at Auckland City Hospital in Auckland, New Zealand. “Tenzing-based delivery can reduce procedure time and may reduce complications. This comprehensive solution will help clinicians overcome challenging neurovascular anatomy with greater ease and efficiency, providing better care for their patients.”

The FreeClimb 70 Reperfusion System is the first fully integrated solution designed around the Tenzing® 7 delivery catheter, which offers superior navigation and predictable access to occluded distal vessels without the need for a guidewire. The system’s advanced design eliminates the ledge effect commonly found in large-bore catheters.

“Route 92 Medical aims to provide neurovascular interventionists with innovative endovascular thrombectomy solutions, helping them maximize their opportunity to restore blood flow to the brain on their first attempt,” said Tony Chou, CEO of Route 92 Medical. “The 510(k) clearance for the FreeClimb 70 Reperfusion System is a key addition to our portfolio of products that are designed to simplify removal of the embolus and seek to improve outcomes.”

The FreeClimb 70 Reperfusion System is part of Route 92 Medical’s growing catalog of endovascular interventional devices being designed to refine and stroke treatment. The company is currently recruiting participants for the SUMMIT MAX clinical trial, which will support regulatory submissions for the next-generation Monopoint® Platform, a super-bore HiPoint™ 88 catheter delivered with Tenzing 8 for thrombectomy procedures.

For more information about the FreeClimb 70 Reperfusion System, visit www.route92medical.com/products. For more information about the SUMMIT MAX clinical trial and the HiPoint 88 and Tenzing 8, visit https://www.route92medical.com/clinical/.

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.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/90284880-82ed-4269-96f5-e1d4b04ccdba

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Gwen Gordon
gwen@gwengordonpr.com