InspireMD’s Pivotal Study on CGuard Prime Stent System: A Potential Game-Changer

InspireMD Inc ((NSPR)) announced an update on their ongoing clinical study.

Study Overview: InspireMD Inc. is conducting a pivotal study titled A Multicenter, Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System (80cm) When Used in Conjunction With the FDA-cleared ENROUTE Transcarotid Neuroprotection System (NPS) in Patients at High Risk for Adverse Events From Carotid Endarterectomy Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization (TCAR) Approach. The study aims to assess the acute device and technical success of the CGuard Prime™ Carotid Stent System in treating carotid artery stenosis in high-risk patients.

Intervention/Treatment: The intervention being tested is the CGuard Prime 80cm stent system, a device designed to be used with the ENROUTE NPS during TCAR procedures. Its purpose is to improve outcomes for patients with carotid artery diseases who are at high risk for adverse events from traditional carotid endarterectomy.

Study Design: This interventional study follows a single-group model without masking. The primary purpose is treatment, focusing on evaluating the technical success of the intervention in a real-world setting.

Study Timeline: The study began on October 20, 2024, with the last update submitted on May 30, 2025. These dates are crucial as they mark the study’s progression and provide a timeline for potential results and conclusions.

Market Implications: The successful outcome of this study could positively impact InspireMD’s stock performance by strengthening investor confidence in their innovative solutions for carotid artery diseases. As the study progresses, it may also influence the competitive landscape, prompting other companies in the medical device industry to enhance their offerings.

The study is currently ongoing, and further details can be found on the ClinicalTrials portal.