Terumo Neuro has announced the publication of results from the RAGE study in the Journal of NeuroInterventional Surgery (JNIS). RAGE is described by Terumo Neuro as the largest prospective, core laboratory-adjudicated, externally monitored trial of endovascular coil embolisation for ruptured intracranial aneurysms conducted in North America, providing “robust contemporary evidence” supporting the safety and effectiveness of the company’s second-generation HydroCoil embolic system (HES) in clinical practice.
This multicentre, non-randomised study enrolled more than 750 adult patients across 45 North American sites—100% of whom had ruptured, saccular intracranial aneurysms—reflecting real-world treatment using current techniques and strategies. Terumo Neuro claims that RAGE delivers high-quality, peer-reviewed data with sufficient scale to support meaningful subset analyses and evaluation of key variables impacting the effectiveness, safety and durability of endovascular coiling in this high-risk patient population.
“The publication of the RAGE study represents another important benchmark for endovascular aneurysm treatment,” said study author David Fiorella (Stony Brook Medicine, Stony Brook, USA). “It builds upon other high-quality studies, like GREAT and HEAT, which have consistently demonstrated the continual evolution in the safety and effectiveness of coil embolisation for the treatment of ruptured cerebral aneurysms with the HES. Over the years, we have appreciated progressively improved clinical and angiographic outcomes for these patients with increasing occlusion rates and durability as well as exceedingly low re-rupture rates.”
RAGE study results
As detailed in a Terumo Neuro press release, RAGE met its primary effectiveness and safety objectives, demonstrating outcomes that compare favourably with historical benchmarks for bare platinum coil embolisation in ruptured aneurysms. Key findings include:
- An adequate occlusion rate of 86%, which is statistically superior to the 80.4% performance goal established by the CLARITY study of bare platinum coils
- An exceptionally low aneurysm rebleeding rate of 0.5%, compared with approximately 1% per year reported in the CARAT study and a 2.4% early rebleeding rate observed in the ISAT trial
- Strong functional independence, with 88% of patients achieving a modified Rankin scale (mRS) score ≤2, comparing favourably with outcomes reported in CLARITY and ISAT
These results reinforce the role of Hydrogel coils as a safe and durable embolisation solution in the acute management of ruptured intracranial aneurysms—a condition associated with significant morbidity and mortality—according to Terumo Neuro.
“Terumo Neuro is committed to advancing clinically meaningful solutions grounded in rigorous evidence,” commented Nagesh Uppuluri, the company’s senior vice president of global clinical and medical affairs. “The publication of RAGE in JNIS underscores our long‑term investment in large‑scale, high‑quality clinical research, and our partnership with leading investigators to address some of the most challenging conditions in neurovascular care.”
New WEB launch
Earlier this month, Terumo Neuro also shared that it has launched the WovenEndoBridge (WEB) 17 aneurysm embolisation system in Japan, expanding treatment options for patients with ruptured and unruptured intracranial aneurysms.
The WEB 17 system received regulatory approval in Japan in November 2025, the company further notes.
“With the introduction of the WEB 17 system, it has become possible to provide safer treatment for off-axis aneurysms, shallow-basined aneurysms, and small aneurysms—cases for which the conventional WEB 21 system offered only limited applicability,” said Akira Ishii (Juntendo University Hospital, Tokyo, Japan). “As a result, the indications for treatment with the WEB system have expanded, and it is expected to become the first-line option for bifurcation aneurysms going forward. In addition, the WEB 17 system offers significantly improved operability compared with the previous generation, underscoring Terumo’s high level of technological capability and accelerating the future adoption of therapy with the WEB system.”
“We are extremely proud to be launching the WEB 17 system in Japan,” added Hiroshi Tada, general manager for Terumo Neuro in Japan. “This clinically proven solution expands physicians’ treatment options for patients with complex aneurysms and reflects our continued commitment to advancing neurovascular care through meaningful innovation.”
