Safety and effectiveness assessment of the surpass evolve (SEASE): a post-market international multicenter study
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View abstract on PubMed
Summary
This summary is machine-generated.The Surpass Evolve (SE) flow diverter shows high effectiveness in treating intracranial aneurysms (iAs), with a 73% complete occlusion rate. This study confirms its favorable safety profile in real-world international use.
Area Of Science
- Endovascular neurosurgery
- Cerebrovascular disease management
- Medical device technology
Background
- Intracranial aneurysms (iAs) are a significant cause of morbidity and mortality.
- Flow diverters represent a first-line treatment for specific iAs.
- Limited data exists on the new-generation Surpass Evolve (SE) 64-wire flow diverter.
Purpose Of The Study
- To evaluate the safety and effectiveness of the Surpass Evolve (SE) flow diverter.
- To report the first international real-world experience with the SE device.
- To assess complete occlusion rates and major adverse events following SE implantation for iAs.
Main Methods
- A multicenter, retrospective, international, post-marketing cohort study (SEASE) was conducted.
- Consecutive patients treated with SE for iAs between 2020-2022 were included.
- Primary endpoints were complete aneurysm occlusion (Raymond-Roy Class 1) and major safety events (ischemia, hemorrhage, mortality).
Main Results
- 305 patients with 332 iAs were treated with SE.
- Median follow-up was 10.2 months, with 73.0% complete occlusion rate.
- Major stroke occurred in 2% and procedure-related mortality in 0.7% of cases.
Conclusions
- The Surpass Evolve (SE) flow diverter demonstrates high effectiveness in achieving complete occlusion of intracranial aneurysms.
- SE exhibits a favorable safety profile, with low rates of major ischemic events and mortality.
- This study supports the use of SE as a reliable treatment option for intracranial aneurysms in real-world clinical practice.
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