Tag: Cguard

InspireMD Announces Completion of Enrollment in C-Guardians U.S. Investigational Device Exemption (IDE) Clinical Trial

Trial designed to support potential U.S. marketing approval of the CGuard™ Prime EPS stent system Study also included first-in-human cases treated with CGuard Prime CAS stent delivery platform Company anticipates study results and Premarket Approval (PMA) submission in H2 2024, potential U.S. approval in H1 2025 TEL AVIV, Israel, June […]

InspireMD Announces Successful First-in-Human Procedure Utilizing CGuard Prime, its Next Generation Carotid Artery Stent (CAS) Platform

Procedure performed as part of the company’s ongoing CGuardians U.S. Investigational Device Exemption (IDE) trial designed to support potential U.S. marketing approval of the CGuard stent system CGuardians enrollment on track to be completed by the end of Q2 2023 TEL AVIV, Israel, May 01, 2023 (GLOBE NEWSWIRE) — InspireMD, […]

InspireMD Announces the Inclusion of its CGuard Carotid Stent in CREST-2 Trial Following FDA Approval of the Investigational Device Exemption Supplement Application

– CGuard™ Carotid Stent will now be a treatment option in the stenting plus medical therapy arm of the trial for patients – – CREST-2 Trial is sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) and actively engaged at more than 140 study locations – TEL AVIV, Israel, Feb. […]

InspireMD Announces Publication of 12-Month Results of CGuard™ EPS SIBERIA Trial in Journals of the American College of Cardiology: Cardiovascular Interventions

TEL AVIV, Israel, Nov. 03, 2021 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease (CAD), today announced that results from the investigator-initiated SIBERIA randomized clinical trial of CGuard EPS, that […]

InspireMD Receives Reimbursement Approval for CGuard™ Embolic Prevention System from the French National Authority for Health

TEL AVIV, Israel, Oct. 13, 2021 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), a global developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announced that its CGuard EPS stent system has received a positive opinion from […]

InspireMD Engages Hart Clinical Consultants to Conduct Clinical Trial for CGuard Carotid Stent System in the United States

TEL AVIV, Israel, Feb. 24, 2021 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, announced today that it has engaged Hart Clinical Consultants (HCC), a leading Contract Research Organization (CRO) to conduct […]

InspireMD Announces Christina Brennan, M.D., MBA to Serve in Advisory Role for Pivotal Study of CGuard Carotid Stent System

Advancing the CARENET-III study of CGuard System for Stroke Prevention in the United States TEL AVIV, Israel, Sept. 10, 2020 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announced […]

InspireMD Announces Approval of Investigational Device Exemption (IDE) for Pivotal Study of CGuard Carotid Stent System

IDE Approval to Pave the Way for Pivotal Study of CGuard System for Carotid Artery Disease and Stroke Prevention in the United States TEL AVIV, Israel, Sept. 08, 2020 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke […]

InspireMD Announces Late-Breaking Presentation of Early SIBERIA Clinical Trial Results to be Featured in an e-Course at EuroPCR

In a head-to-head evaluation, significantly fewer silent brain infarcts were associated with CGuard™ EPS versus Acculink™ at 30 days post-procedure TEL AVIV, Israel, June 25, 2020 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid […]

InspireMD Announces Publication of 12-Month Results of CGuard™ EPS PARADIGM Trial in EuroIntervention

Results indicate that 12 months after carotid intervention the CGuard EPS MicroNET-covered stent delivers sustained protection against postprocedural neurologic events TEL AVIV, Israel, June 10, 2020 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid […]