RegulatoryCompany release

FDA clears InspireMD's CGuard Prime stent for transcarotid artery revascularisation via PMA supplement

🇺🇸 InspireMD, Inc. (NSPR) · Thu 12 Nov 2026

The agency has approved a PMA supplement for the CGuard Prime 80 cm system in TCAR for high-surgical-risk patients, based on the 50-patient CGUARDIANS II trial.

InspireMD announced on 12 November 2026 that the US Food and Drug Administration has approved a premarket approval (PMA) supplement for its CGuard Prime TransCarotid Stent System. The approval covers the 80 cm delivery system.

The device may now be used for transcarotid artery revascularisation (TCAR) together with a labelled embolic protection system. The indication applies to patients at high surgical risk who need carotid revascularisation.

The approval is supported by CGUARDIANS II, a single-arm trial that enrolled 50 patients. According to the company, the study recorded 100% acute device success. It also reported no deaths, strokes, myocardial infarctions or stent thromboses at 30 days.

As general context, a PMA supplement is the route by which a manufacturer seeks FDA approval for changes to a device that already holds a PMA, such as a new indication or a modified delivery system. The source material available does not give further details on labelling conditions or commercial launch plans.

What it means for your team

  • Regulatory teams tracking carotid devices should note that the TCAR indication is tied to use with a labelled embolic protection system, so device pairing matters for compliance.
  • The indication is limited to high-surgical-risk patients, which defines the eligible population for labelling and promotion.
  • The evidence base is a 50-patient single-arm study with 30-day outcomes, so post-approval data on longer-term safety and performance will be of interest to quality and vigilance teams.
  • Market-access teams should wait for company detail on launch timing and coverage before assessing uptake.

Company's press release (SEC filing): InspireMD, Inc. ↗

Article written by VigiEye from the official source (InspireMD, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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