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Route 92 Medical’s FreeClimb system has been added to the Australian Register of Therapeutic Goods, opening access to a neurovascular intervention platform that until now had been limited to special access pathways.
The listing marks the first time the technology has been available outside the United States. Device Technologies will distribute the system across Australia, expanding clinical access to a design that aims to simplify some of the most time-critical procedures in stroke care.
The provider frames FreeClimb as a way to reduce the need for a microcatheter in every case and limit guidewire use in more than 70 per cent of procedures. The design allows clinicians to advance without crossing the clot directly, a feature intended to save valuable time during acute treatment.
First System Of Its Kind In APAC
The FreeClimb platform incorporates the Tenzing delivery catheter, which Route 92 developed to improve navigation and support atraumatic access. It is the first system of its type to enter the APAC region through full regulatory listing.
Device Technologies described the move as an important step for clinicians managing stroke patients. Early adopters report that the technology changes how procedures can be approached, particularly in high pressure situations where speed and control matter.
Shaun Anderson, General Manager Cardiovascular ANZ & Asia at Device Technologies, said the listing broadens access to tools that can support better outcomes.
“Having FreeClimb included on the ARTG is a huge step forward for acute stroke treatment in Australia. This system streamlines the procedure and reduces time to reperfusion for clinicians, and ultimately, it’s about giving patients across Australia and New Zealand the best possible outcomes. We’re really excited to see it making a real difference here,” Anderson said.
Clinicians Report Improved Navigation And Efficiency
Associate Professor, Julian Maingard, Consultant Interventional Neuroradiologist at Austin Health and St Vincent’s Hospital, said the technology has shifted practice in his field.
“Route 92’s FreeClimb system has been a game changer in the treatment of Large Vessel Occlusion strokes. Our practice has moved more and more towards large bore aspiration, and the Route 92 system allows for enhanced navigation to the clot interface for faster and better reperfusion and improved clinical outcomes,” Maingard said.
FreeClimb’s design focuses on reducing friction during catheter navigation, creating a smoother path to the clot interface. The vendor positions these features as a way to reduce procedural complexity in a setting where minutes can affect long term recovery.
Broader Access Through Local Distribution
Device Technologies will distribute the system locally, giving hospitals and clinics a streamlined procurement path now that the platform holds ARTG clearance. The distributor said demand has grown for tools that reduce handling complexity during neurovascular interventions.
Route 92 Medical was founded by physicians seeking to redesign aspects of neurointervention using a procedural approach shaped by clinical experience. The company works with specialists globally to refine its devices, focusing on areas where efficiency gains can influence outcomes for stroke patients.
With the ARTG listing now complete, clinicians across Australia have new options for treating some of the most severe types of stroke with a platform designed to support speed, control and consistency.
Last Updated on December 5, 2025 by Nick Ross
