InspireMD Publishes C-GUARDIANS Trial Results in JACC
MIAMI, Jan. 12, 2026 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), a leader in carotid stent systems, has announced the publication of pivotal trial results from its C-GUARDIANS study in the Journal of the American College of Cardiology (JACC). This groundbreaking research highlights the efficacy and safety of the CGuard® Prime carotid stent system designed to prevent strokes, especially in patients with asymptomatic carotid stenosis.
Key Findings from the C-GUARDIANS Trial
The C-GUARDIANS trial demonstrated the lowest rates of disabling stroke or myocardial infarction (DSMI) in a 30-day period, alongside impressively low ipsilateral stroke rates through one year. This research underpins the safety and effectiveness of carotid artery stenting (CAS) with InspireMD's proprietary MicroNet™ covered stent.
- 30-Day DSMI Rate: 0.95%
- One-Year Ipsilateral Stroke Rate: 1.93%
- Patient Cohort: 25% were symptomatic, a group historically at high risk.
The trial also reported no unexpected device-related adverse events, setting a new standard in the field of carotid stenting. These results were first presented at the VIVA conference in late 2023 and subsequently at LINC in mid-2024.
Expert Commentary
Dr. Chris Metzger, M.D., an interventional cardiologist and lead investigator of the C-GUARDIANS trial, emphasized the significance of these findings, stating, "The C-GUARDIANS results are exceptional, reflecting the lowest reported event rates in patients traditionally regarded as high-risk." He noted the implications of achieving such outcomes in a cohort that included a significant percentage of symptomatic patients.
Implications for the Interventional Community
According to Peter Soukas, M.D., Chief Medical Advisor of InspireMD, this publication represents a critical advancement in the transition towards stent-system strategies for carotid revascularization. He stated, "Clinicians are increasingly seeking validated technologies that enhance patient eligibility while maintaining excellent outcomes." The positive trial data offer strong clinical validation for broader adoption of the CGuard® Prime system.
Company Perspective
Marvin Slosman, CEO of InspireMD, commented on the publication of the trial results, indicating that peer-reviewed evidence strengthens their position in the market. "This validation highlights years of innovation and clinical rigor behind CGuard® Prime, poised to benefit thousands of U.S. patients," he said, adding that the publication's impact on physician engagement is expected to be substantial.
About the C-GUARDIANS Clinical Trial
The C-GUARDIANS trial evaluated the safety and efficacy of the CGuard® Carotid Stent System for treating carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in both the United States and Europe. The primary endpoint assessed major adverse events, including all-cause mortality, stroke, or myocardial infarction (DSMI), within 30 days post-procedure during a follow-up period lasting from 31 to 365 days.
About InspireMD, Inc.
InspireMD aims to establish its MicroNet™ technology as the industry standard for carotid stenting, ensuring exceptional acute results coupled with long-term stroke-free outcomes. The company’s stock is publicly traded on Nasdaq under the ticker symbol NSPR. For further information, visit www.inspiremd.com.
Investor Contact
For additional inquiries, please contact:
- Webb Campbell
- Gilmartin Group LLC
- Email: webb@gilmartinir.com
- Email: investor-relations@inspiremd.com