InspireMD wins FDA approval for CGuard Prime TCAR stent, doubling US addressable market

InspireMD, Inc.

• FDA approved the PMA supplement for the CGuard Prime TransCarotid Stent System (80 cm delivery) for TCAR procedures used with an embolic protection system specified in labeling.
• Approval adds access to more than 35,000 annual US TCAR procedures, doubling CGuard Prime's TAM; TCAR plus CAS total ~75,000 US carotid stenting procedures yearly per company estimates.
• CGUARDIANS II pivotal trial: 50 patients across 11 US sites; 100% acute device success with zero death, stroke, MI or stent thrombosis at 30 days.
• Commercial entry can proceed independently of the investigational SwitchGuard NPS, which is still enrolling in the CGUARDIANS III pivotal trial.
• CEO Marvin Slosman called it a 'strong near-term growth driver' and said InspireMD is the first company with both CAS and TCAR delivery options.