InspireMD, Inc. is medical device company, which engages in the development and commercialization of its proprietary MicroNet stent platform technology for the treatment of complex vascular and coronary disease. Its products are marketed for use mainly in patients with acute coronary syndromes, notably acute myocardial infarction and saphenous vein graft coronary interventions. The company was founded in 2005 and is headquartered in Tel Aviv, Israel.
Clinical Trials
9
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
11.1%
Completed
3
33.3%
Not yet recruiting
1
11.1%
Recruiting
1
11.1%
Terminated
2
22.2%
Withdrawn
1
11.1%
No approval data available
- The FDA has approved InspireMD's Investigational Device Exemption application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system for stroke prevention. - The study will evaluate next-generation enhancements to the SwitchGuard system for use with the CGuard Prime 80 cm stent platform in transcarotid artery revascularization procedures. - InspireMD targets a U.S. commercial launch of the SwitchGuard NPS in 2027, pending regulatory approval following successful completion of the pivotal trial. - The study will be led by the same investigators who conducted the previous CGUARDIANS II trial, ensuring continuity in clinical development.
- InspireMD's CGuard Prime Carotid Stent System received FDA premarket approval based on the C-GUARDIANS pivotal trial showing the lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates of any carotid intervention study. - The device features proprietary MicroNet mesh technology that combines the largest open-cell frame with the smallest mesh pore size to prevent plaque protrusion and provide sustained embolic protection beyond five years. - The approval triggers a $17.9 million warrant tranche from InspireMD's $113.6 million financing agreement and enables immediate commercial launch in the United States following prior CE Mark approval in Europe. - The C-GUARDIANS trial enrolled 316 patients across 24 sites in the US and Europe, with 25% being symptomatic patients at high risk for carotid endarterectomy surgery.
• InspireMD partners with NAMSA to conduct the CGUARDIANS II pivotal study, evaluating the CGuard Prime 80 cm carotid stent system in TCAR procedures. • The CGUARDIANS II trial is a prospective, multi-center, single-arm study aiming to enroll at least 50 patients at high risk for adverse events from carotid endarterectomy. • The study assesses the acute device and technical success of CGuard Prime when used with an FDA-cleared TCAR neuro-protection system. • First patient enrolled in December 2024, marking progress toward potential FDA approval and expansion into the growing TCAR market.
• InspireMD received FDA approval for its IDE application to begin the CGUARDIANS II pivotal study of the CGuard Prime 80cm Carotid Stent System. • The study will evaluate the CGuard Prime stent during transcarotid revascularization (TCAR) procedures for stroke prevention. • Patrick Geraghty, M.D., and Patrick Muck, M.D., will serve as lead investigators for the CGUARDIANS II trial. • InspireMD aims to secure approval for CGuard Prime in TCAR procedures and advance its next-generation TCAR Neuroprotection System.
• InspireMD has submitted a premarket approval (PMA) application to the FDA for its CGuard Prime carotid stent system, designed for treating carotid artery stenosis. • The PMA application is based on positive one-year data from the C-GUARDIANS pivotal clinical trial, which involved 316 patients across 24 sites in the U.S. and Europe. • C-GUARDIANS demonstrated a primary endpoint major adverse event rate of 1.95% at 12 months, the lowest reported for any carotid stent pivotal trial. • The CGuard EPS system, designed to prevent stroke, previously received CE mark and utilizes MicroNet technology for strong acute results and durable, stroke-free, long-term outcomes.
- InspireMD has submitted a Premarket Approval (PMA) application to the FDA for its CGuard Prime carotid stent system, aimed at preventing stroke. - The PMA is supported by positive data from the C-GUARDIANS clinical trial, which demonstrated a low major adverse event rate of 1.95% at one year. - The C-GUARDIANS trial enrolled 316 patients across U.S. and European sites, evaluating the safety and efficacy of CGuard for carotid artery stenosis. - If approved, InspireMD anticipates a U.S. commercial launch of the CGuard Prime system in the first half of 2025.
• InspireMD has submitted a Premarket Approval application to the FDA for its CGuard Prime carotid stent system, designed to prevent stroke by treating carotid artery stenosis. • The application is based on the C-GUARDIANS clinical trial, which reported a low major adverse event rate of 1.95% at one year post-procedure. • InspireMD is preparing for a potential U.S. commercial launch of CGuard Prime in the first half of 2025, pending FDA approval, and is setting up commercial infrastructure. • The CGuard Prime system utilizes InspireMD's MicroNet technology and aims to become the industry standard for carotid stenting with superior acute and long-term outcomes.
