Tag: InspireMD

InspireMD Announces First Patient Enrolled in the CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System for Use in TCAR Procedures

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MIAMI, June 08, 2026 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced that the first patient has been enrolled in the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system (“NPS”), for use with its CGuard Prime 80 cm stent platform, in transcarotid artery revascularization (“TCAR”) procedures. The patient was enrolled by Dr. Patrick Muck at Good Samaritan Hospital, part of the TriHealth System in Cincinnati, Ohio.

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InspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System

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MIAMI, May 01, 2026 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced that the U.S. Food and Drug Administration (“FDA”) has approved the company’s Investigational Device Exemption (“IDE”) Application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system (“NPS”), including next generation enhancements from our prior IDE approval for use with its CGuard Prime 80 cm stent platform, in transcarotid artery revascularization (“TCAR”) procedures.

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Landmark CREST-2 Study Published in the New England Journal of Medicine Highlights the Benefits of Carotid Artery Stenting

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Carotid artery stenting combined with medical therapy demonstrated a significantly lower stroke risk compared to intensive medical therapy alone in patients with severe asymptomatic carotid stenosis Carotid artery stenting combined with medical therapy demonstrated a significantly lower stroke risk compared to intensive medical therapy alone in patients with severe asymptomatic carotid stenosis

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InspireMD Names Peter A. Soukas, M.D., as Chief Medical Officer

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MIAMI, Nov. 03, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the appointment of Peter A. Soukas, M.D., as Chief Medical Officer to advance its mission to deliver best-in-class tools for carotid intervention.

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InspireMD Announces the Appointment of Dan Dearen to its Board of Directors

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MIAMI, Sept. 17, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the appointment of Dan Dearen to its Board of Directors. Mr. Dearen brings nearly 40 years of leadership experience in the medical device and life sciences sectors, with a proven track record of guiding MedTech companies through critical financial milestones and delivering shareholder value through execution.

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InspireMD Announces the Appointment of Raymond W. Cohen to its Board of Directors

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MIAMI, July 31, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the appointment of Raymond W. Cohen to its Board of Directors. Mr. Cohen has over 40 years of leadership experience in medical technology with a successful track record of scaling commercial operations and creating shareholder value through market leadership and successful exit transactions.

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InspireMD Announces FDA Approval for CGuard® Prime Carotid Stent System for the Prevention of Stroke

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MIAMI, June 24, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (the “Company”) (Nasdaq: NSPR), developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket application (PMA) approval of the CGuard Prime Carotid Stent System in the United States.

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InspireMD Announces CE Mark Approval for CGuard® Prime Embolic Prevention System (EPS) Under European MDR for the Prevention of Stroke

Neuro Regulatory by Comments are Disabled

MIAMI, June 13, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the company has received CE Mark approval under the European Medical Device Regulation (MDR) for the CGuard® Prime EPS.

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