US-based Route 92 Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for the FreeClimb 54 reperfusion system.

FreeClimb 54 reperfusion system includes the FreeClimb 54 aspiration catheter with a Tenzing 5 delivery catheter.

The system is designed to enable physicians to swiftly and reliably access and eliminate stroke-inducing clots in endovascular thrombectomy procedures.

Using sturdy tip and shaft design, it supports multiple passes and integrates smoothly with various other technologies.

Additionally, the FreeClimb 54 system can remove distal clots in cases where first-line therapies fail in complete clot removal.

Route 92 Medical CEO Tony Chou said: “Route 92 Medical works to provide innovative endovascular thrombectomy solutions to clinicians, helping them maximise their opportunity to restore blood flow to the brain on their first attempt.

“The FreeClimb 54 reperfusion system is an essential addition to our product portfolio, enabling clinicians to use our products to address a wider range of patient needs.”

The product is the latest addition to Route 92 Medical’s portfolio of neurovascular tools. The range is designed to work as a comprehensive endovascular thrombectomy solution for diverse neurovascular procedures.

Route 92 Medical has engineered its FreeClimb and HiPoint product lines to work together and streamline endovascular thrombectomy procedures. The integration empowers physicians to choose the optimal length and size of a catheter for every case.

According to the medical technology firm, the FreeClimb 54 easily pairs with the FreeClimb 70 reperfusion system, along with Route 92 Medical’s FreeClimb 88, HiPoint 70, and HiPoint 88 access systems.

All the systems are powered by custom-sized Tenzing delivery catheters.

The advanced navigational capabilities of these delivery catheters ensure swift and precise delivery to the target lesion. It reduces the need for a microcatheter and enhances procedural efficiency, said the firm.

Route 92 Medical develops treatment for patients undergoing neurovascular intervention. The company raised $31m in a Series F round in November 2023 to accelerate the commercialisation of its intervention portfolio.