newsfilter
← Latest News
GlobeNewswire·

InspireMD Initiates Voluntary U.S. Recall of CGuard® Prime 135 cm Carotid Stent Delivery System

  • InspireMD announced a voluntary U.S. recall of the CGuard Prime 135 cm carotid stent delivery system due to technical performance issues during controlled launch procedures.
  • The recall affects only the delivery system & does not impact the safety of patients who have previously received the CGuard stent implant.
  • Global unit sales grew 53% year-over-year in Q1 2026, while U.S. unit sales grew 34% quarter-over-quarter.
  • FDA approval for the original CGuard delivery system for CAS procedures is anticipated in the third quarter of 2026.
  • Design improvements are being implemented for the CGuard Prime delivery system, with FDA approval for the enhanced version expected in the first half of 2027.
  • FDA approval for the CGuard Prime 80 cm delivery system for TCAR procedures is anticipated during the second half of 2026.
  • InspireMD withdrew its full-year 2026 revenue guidance following the temporary discontinuation of U.S. commercial activity.
  • The company plans to provide a full update on these developments during its Q1 2026 results conference call on May 4, 2026.