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Device Technologies has announced that the Bentley BeFlared Stent Graft System has been listed on the Australian Register of Therapeutic Goods (ARTG), clearing the way for routine clinical use in Australia.
The device, manufactured by Bentley, is described as the first dedicated bridging stent designed specifically for complex Fenestrated EndoVascular Aneurysm Repair (FEVAR) procedures.
It has been listed under ARTG 523842.
What the device does
FEVAR is a procedure used to treat complex aortic aneurysms. The BeFlared stent is designed to bridge fenestrations – custom openings in an endovascular graft – to maintain blood flow to branch vessels during the repair.
The device features a stepped balloon intended to allow precise, one-step deployment, reducing the number of procedural steps required. It also includes an additional radiopaque marker to improve accuracy during fluoroscopy-guided placement.
Already used in 384 Australian cases
While the ARTG listing is new, the BeFlared stent has already been used in clinical practice under special access provisions.
Since the first-in-human procedure, performed by Prof. Stephan Haulon in Paris in late 2024, the device has been implanted in patients worldwide, including 384 cases in Australia.
Reports from specialists who have used the device indicate it reduces both procedural and fluoroscopy time during fenestrated endografting.
Device Technologies distributes in Australia
Device Technologies, which distributes the BeFlared in Australia, described the ARTG listing as a significant step for the product’s availability.
Lisa Kirsh, Director of Sales, Surgical and Hospital at Device Technologies, welcomed the listing.
“We’re thrilled to see BeFlared included on the ARTG. It’s a great moment for both the medical community and the patients who benefit from innovations like this,” Kirsh stated.
“Device Technologies is proud to be part of a team that’s enabling these advancements and supporting doctors in pushing the boundaries of what’s possible in vascular care.”
What the ARTG listing means
Inclusion on the ARTG means the BeFlared can now be supplied in Australia through standard commercial channels, rather than relying on the special access scheme that was used during its initial rollout. The listing provides a regulatory pathway for broader clinical adoption across Australian hospitals performing complex aortic repair.
Last Updated on March 17, 2026 by Nick Ross
