InspireMD reports positive 30-day outcomes from CGUARDIANS II trial
InspireMD reported 100% acute device success and zero major adverse events in the 30-day outcomes from the CGUARDIANS II trial for the CGuard Prime 80cm implant. No stent thrombosis was observed, and complete stent patency was noted in evaluable subjects. The company expects potential approval of the implant in the second half of this year.
*this image is generated using AI for illustrative purposes only.
InspireMD, Inc. announced positive 30-day outcomes from the CGUARDIANS II clinical trial evaluating the CGuard Prime 80cm implant for use in transcarotid artery revascularization (TCAR) procedures. The trial demonstrated 100% acute device success with no reported deaths, strokes, or myocardial infarctions within the 30-day period. The company anticipates potential approval of the CGuard Prime 80cm stent implant in the second half of this year.
Key Trial Outcomes
The CGUARDIANS II trial evaluated the safety and performance of the CGuard Prime 80cm implant. The primary focus was on acute device success and the absence of major adverse events within the first month post-procedure.
| Metric | Outcome |
|---|---|
| Acute device success | 100% (50/50 patients) |
| Deaths, strokes, or myocardial infarctions (30 days) | 0 |
| Stent thrombosis (30 days) | 0 |
| Complete stent patency (30 days) | Observed in evaluable subjects |
The absence of stent thrombosis and the observation of complete stent patency in evaluable subjects further support the safety profile of the device. These results are critical for the company's regulatory submission and anticipated approval timeline.
How will the anticipated approval of the CGuard Prime 80cm stent impact InspireMD's market share in the TCAR procedure market?
What are the potential challenges in scaling up production to meet demand post-approval?
How might these results influence the adoption of CGuard Prime in other vascular procedures?
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