Route 92 Medical has today announced receipt of 510(k) clearance from the US Food and Drug Administration (FDA) for its FreeClimb 70 reperfusion system, which includes the FreeClimb 70 aspiration catheter along with the Tenzing 7 delivery catheter.
The FreeClimb 70 reperfusion system enables physicians to treat patients experiencing an acute ischaemic stroke by removing clots rapidly and safely, a company press release notes. 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, the release adds.
“In our initial experience with FreeClimb 70 and Tenzing 7, the system easily delivered to the target occlusion allowing rapid, effective and safe reperfusion,” said James Caldwell (Auckland City Hospital, Auckland, New Zealand), an early user of the system. “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.”
According to Route 92, 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 is also intended to eliminate the ‘ledge effect’ commonly found in large-bore catheters.
“Route 92 Medical aims to provide neurovascular interventionists with innovative endovascular thrombectomy solutions, helping them maximise their opportunity to restore blood flow to the brain on their first attempt,” said Tony Chou, CEO of Route 92. “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’s growing catalogue of endovascular interventional devices being designed to refine 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.