InspireMD Says FDA Approved Investigational Device Exemption Application To Initiate CGUARDIANS II Pivotal Study Of CGuard Prime 80cm Carotid Stent System During TCAR Procedures
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InspireMD has received FDA approval for an Investigational Device Exemption application to begin the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent System, which will be used during TCAR procedures.
October 07, 2024 | 11:01 am
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InspireMD has received FDA approval to start a pivotal study for its CGuard Prime 80cm Carotid Stent System, potentially advancing its product offerings and market position.
The FDA approval for the pivotal study is a significant regulatory milestone for InspireMD, indicating potential future product advancements and market expansion. This news is likely to positively impact NSPR's stock price in the short term as it reflects progress in their product pipeline.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100