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InspireMD

Ownership
-
Employees
66
Market Cap
-
Website
Introduction

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

8

Active:1
Completed:3

Trial Phases

2 Phases

Phase 4:2
Not Applicable:3

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (5 trials with phase data)• Click on a phase to view related trials

Not Applicable
3 (60.0%)
Phase 4
2 (40.0%)

A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach

Not Applicable
Recruiting
Conditions
Carotid Artery Diseases
First Posted Date
2024-10-22
Last Posted Date
2025-05-31
Lead Sponsor
InspireMD
Target Recruit Count
50
Registration Number
NCT06653387
Locations
🇺🇸

UC Davis Health, Sacramento, California, United States

🇺🇸

Indiana University School of Medicine, Indianapolis, Indiana, United States

🇺🇸

Allina, Minneapolis, Minnesota, United States

and more 5 locations

Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting

Not Applicable
Active, not recruiting
Conditions
Carotid Artery Stenosis
First Posted Date
2021-05-25
Last Posted Date
2025-04-04
Lead Sponsor
InspireMD
Target Recruit Count
317
Registration Number
NCT04900844
Locations
🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

🇺🇸

University of Florida, Jacksonville, Florida, United States

🇺🇸

Oschner Health, New Orleans, Louisiana, United States

and more 15 locations

MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction

Terminated
Conditions
ST Elevation Myocardial Infarction
First Posted Date
2014-11-17
Last Posted Date
2015-09-02
Lead Sponsor
InspireMD
Target Recruit Count
63
Registration Number
NCT02292823
Locations
🇳🇱

Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands

OCT Study of the MGuard Prime Stent in Patients With Heart Attacks

Phase 4
Withdrawn
Conditions
ST Segment Elevated Myocardial Infarction
First Posted Date
2014-08-21
Last Posted Date
2015-03-31
Lead Sponsor
InspireMD
Registration Number
NCT02222116
Locations
🇬🇧

Norfolk and Norwhich Hospital, Norfolk, United Kingdom

MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial Infarction

Not Applicable
Terminated
Conditions
ST Elevation Myocardial Infarction
First Posted Date
2013-06-05
Last Posted Date
2015-09-02
Lead Sponsor
InspireMD
Target Recruit Count
310
Registration Number
NCT01869738
Locations
🇺🇸

Yale University School of Medicine, New Haven, Connecticut, United States

🇺🇸

Pepin Heart Hospital, Tampa, Florida, United States

🇺🇸

Alexian Brothers Medical Center, Elk Grove Village, Illinois, United States

and more 53 locations
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News

InspireMD Receives FDA Approval for CGuard Prime Carotid Stent System with Record-Low Stroke Rates

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.

InspireMD's CGuard Prime Stent Evaluated in CGUARDIANS II TCAR Trial

• 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 Receives FDA IDE Approval for CGuard Prime Carotid Stent Pivotal Study

• 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 Submits CGuard Carotid Stent for FDA Approval

• 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 Submits FDA Premarket Approval Application for CGuard Prime Carotid Stent System

InspireMD has submitted a Premarket Approval (PMA) application to the FDA for its CGuard Prime carotid stent system, aimed at preventing stroke.

InspireMD Seeks FDA Approval for CGuard Prime Carotid Stent System After Positive Trial Results

• 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.

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