San Mateo, California-based Route 92 designed the reperfusion system with the FreeClimb 70 aspiration catheter. It also features a Tenzing 7 delivery catheter.
The system enables physicians to treat patients experiencing acute ischemic stroke by removing clots rapidly and safely. Route 92 said it offers a more refined bi-axial approach for restoring blood flow to the brain during endovascular thrombectomy procedures.
Dr. James Caldwell, an early user, said the system offers easily delivery to the target occlusion for effective, safe reperfusion. Caldwell used the system at Auckland City Hospital in Auckland, New Zealand.
“Tenzing-based delivery can reduce procedure time and may reduce complications,” Caldwell said. “This comprehensive solution will help clinicians overcome challenging neurovascular anatomy with greater ease and efficiency, providing better care for their patients.”
The fully integrated solution features a design around the Tenzing 7 delivery catheter. Route 92 said it offers superior navigation and predictable access to occluded distal vessels. It also removes the need for a guidewire. According to the company, the 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.”