Image: InspireMD
Nov. 24, 2025 — InspireMD, Inc., developer of the CGuard Prime carotid stent system for the prevention of stroke, welcomes the recent presentation and publication of CREST-2 data which demonstrated positive clinical outcomes for carotid artery stenting (CAS) for patients with asymptomatic carotid stenosis. CREST-2 data was shown at The Society of Vascular and Interventional Neurology (SVIN) Annual Meeting and the Vascular and Endovascular Issues Techniques and Horizons (VEITH) Symposium on Nov. 21, 2025. In conjunction, the CREST-2 study was published in the New England Journal of Medicine.
CREST-2 showed that, among patients with high-grade carotid stenosis without recent neurological symptoms, the addition of stenting led to significantly better outcomes than intensive medical management alone, as measured by a decreased risk of the composite of perioperative stroke or death or ipsilateral stroke within 4 years. In a separate arm of the same trial, carotid endarterectomy (CEA) did not achieve a significant benefit for these patients as compared to intensive medical management alone.
"The publication of CREST-2 data is an important moment for the treatment of carotid disease,” said Peter Soukas, M.D., Chief Medical Advisor of InspireMD. “These data meaningfully clarify the role of carotid stenting as a front-line treatment for patients with asymptomatic carotid stenosis, confirming the results that many of us in the field have achieved for a long time. Physicians and patients now have definitive, high-quality evidence that CAS is an effective treatment option for these patients.”
“CREST-2 validates what we have long believed – that the combination of carotid artery stenting with medical management is superior to medical therapy alone in the treatment of asymptomatic carotid disease,” said Marvin Slosman, Chief Executive Officer of InspireMD. “The trial also highlights the value of our innovative mesh protected platform. In our C-GUARDIANS pivotal trial, CGuard demonstrated a record-low 1.93% major adverse event rate through 12 months, even when exclusively enrolling high surgical risk patients, one-quarter of whom were symptomatic. Our device is also supported by more than 65,000 global implants and extensive real-world evidence. Combined with the landmark results from the CREST-2 trial, we remain well positioned to advance the shift to an endovascular-first approach in this segment of vascular disease.”
About CREST-2
CREST-2 was a NIH sponsored independently conducted set of two parallel, observer-blinded clinical trials across 155 centers globally. The stenting trial compared intensive medical management alone (medical-therapy group) with carotid-artery stenting plus intensive medical management (stenting group); the endarterectomy trial compared intensive medical management alone (medical-therapy group) with carotid endarterectomy plus intensive medical management (endarterectomy group).
The primary outcome was a composite of any stroke or death, assessed from randomization to 44 days, or ipsilateral ischemic stroke, assessed during the remaining follow-up period up to 4 years. A total of 1245 patients underwent randomization in the stenting trial and 1240 in the endarterectomy trial. The study was published in the New England Journal of Medicine on Nov. 21, 2025. The study was neither funded nor published by InspireMD.
October 13, 2025 
