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

Tuesday, April 25, 2023

Route 92 Medical, Inc., a leading medical technology company focused on enhancing outcomes for patients undergoing neurovascular intervention, has announced the 510(k) clearance for its innovative FreeClimb™ 70 Reperfusion System. This advanced system, consisting of the FreeClimb 70 Aspiration Catheter and Tenzing® 7 Delivery Catheter, enables physicians to efficiently and safely remove clots in patients with acute ischemic stroke. With superior deliverability and procedural efficiency, the FreeClimb 70 Reperfusion System offers a refined bi-axial approach for restoring blood flow during endovascular thrombectomy procedures.

Early users of the system have reported positive experiences, emphasizing its rapid, effective, and safe reperfusion capabilities. The Tenzing-based delivery catheter streamlines the procedure, potentially reducing complications and procedure time. By overcoming challenging neurovascular anatomy with ease and efficiency, this comprehensive solution empowers clinicians to deliver better care to their patients.

The FreeClimb 70 Reperfusion System stands out as the first fully integrated solution centered around the Tenzing® 7 delivery catheter, offering exceptional navigation and predictable access to occluded distal vessels without requiring a guidewire. Its advanced design eliminates the common ledge effect observed in large-bore catheters.

Tony Chou, CEO of Route 92 Medical, expressed the company's commitment to providing innovative endovascular thrombectomy solutions, enabling neurovascular interventionists to maximize their potential for successful blood flow restoration. The 510(k) clearance for the FreeClimb 70 Reperfusion System reinforces Route 92 Medical's dedication to simplifying embolus removal and improving patient outcomes.

The FreeClimb 70 Reperfusion System is part of Route 92 Medical's expanding portfolio of endovascular interventional devices, designed to advance stroke treatment. The company is actively 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.



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