Long-Term Data Presented From European Registries of InspireMD's CGuard EPS
November 29, 2018—InspireMD, Inc. announced that updated data on the company's CGuard embolic prevention system (EPS) for the prevention of stroke caused by the treatment of carotid artery disease were presented at the 45th annual VEITHsymposium held November 13–17 in New York, New York. The results of three separate registries confirm the long-term benefits of CGuard EPS in preventing late embolic events.
First, Professor Piotr Musialek, MD, presented an update of his ongoing PARADIGM-Extend clinical trial of 251 all-comers patients with high-risk carotid stenosis treated with the CGuard EPS.
In the company's announcement, Prof. Musialek noted, "CGuard EPS delivers excellent safety and efficacy both during the procedure and at long-term 36-month follow-up. This is especially encouraging as this is an all-comers registry, which includes patients with high-risk carotid lesions such as aneurysms, dissections, or highly calcified lesions. I am not aware of any other device that has demonstrated such sustained long-term benefits.” Prof. Musialek is with the Department of Cardiac and Vascular Diseases at John Paul II Hospital in Krakow, Poland.
Next, Professor Christian Wissgott, MD, presented 6-month follow-up data on 70 consecutive patients treated with the CGuard EPS. The data presented mirror Prof. Musialek’s results. Among the findings, the CGuard EPS demonstrated a 100% technical success rate. Additionally, there were no observed preinterventional complications or peri- or postinterventional strokes. At 6 months, no intrastent restenosis was observed, and diffusion-weighted MRI data from 29 of the 70 patients detected no new ipsilateral lesions in the brain after 30 days or 6 months.
Prof. Wissgott stated, “The novel CGuard EPS with the combination of an open-cell nitinol stent and a micromesh cover leads to the prevention of postprocedural embolic events. The CGuard is easy and safe to implant due to its very smooth wall adaption to the vessel wall and lack of foreshortening.” Prof. Wissgott is Director at Westküstenklinikum Heide in Heide, Germany.
Finally, Laura Capoccia, MD, and Francesco Speziale, MD, presented an update on the ongoing IRONGUARD 2 multicenter prospective registry study of 342 patients with severe carotid artery stenosis. The presentation included data from 15 centers and showed no major stroke, permanent neurologic symptoms, restenosis, or neurologic deaths in 51 of the 342 patients who completed 1-year follow-up. Drs. Capoccia and Speziale are with the Vascular and Endovascular Surgery Division at the University of Rome in Rome, Italy.