Miami-based InspireMD launched CGuard Prime in the U.S. in July 2025 after receiving FDA premarket approval (PMA) the previous month. As of May, it reported 70,000 successful cases worldwide, including the majority of clinical cases in its CGUARDIANS clinical trial.
However, the company recalled its CGuard Prime 135 cm carotid stent delivery system last month due to a failure to meet performance expectations. It anticipates FDA approval for design improvements in the first half of 2027.
CGUARDIANS II, a prospective, multi-center, single-arm pivotal study evaluates the CGuard Prime stent implant for TCAR (transcarotid artery revascularization). It enrolled 50 patients across 11 sites to assess acute device and technical success when used in conjunction with the FDA-cleared EnRoute TCAR neuro-protection system in patients considered at high risk for adverse events from carotid endarterectomy.
The company hopes to bring the CGuard Prime system to TCAR this year, as remains under review for FDA premarket approval (PMA). It anticipates that approval in the second half of this year.
In CGUARDIANS II, investigators observed acute device success in 100% (50/50) patients. They saw no deaths, strokes or myocardial infarctions within 30 days, as well as no stent thrombosis in that time frame. The study also saw complete stent patency at 30 days in evaluable subjects.
Commentary from InspireMD officials and investigators
Marvin Slosman, CEO of InspireMD, said:
“We believe the 30-day CGUARDIANS II results represent a significant achievement in our quest to tap into the large and growing TCAR market. Together with our recently initiated CGUARDIANS III clinical trial of our proprietary SwitchGuard neuroprotection system, we potentially have line-of-sight to offering the full TCAR toolkit, subject to regulatory review and approval, leveraging our best-in-class CGuard Prime Carotid Stent System with its unmatched clinical outcomes, for the more than 35,000 TCAR procedures that are performed in the U.S. every year.”
Dr. Patrick J. Geraghty, professor of surgery and radiology at Washington University School of Medicine in St. Louis and co-lead investigator of the CGUARDIANS II study, said:
“The 30-day results observed in the CGUARDIANS II trial suggest that the CGuard Prime 80 cm stent may deliver exceptional safety and efficacy when used with a TCAR approach. Notably, the 100% acute device success rate with zero major adverse events has the potential to make CGuard Prime the gold standard implant for high-risk patients undergoing TCAR procedures. I look forward to incorporating it into my own practice, if approved.”
