Results from the trial were initially presented at the 2017 VEITH Symposium in New York last month.
In the investigator-led study, researchers examined the use of the CGuard EPS system in 101 patients with symptomatic or high-risk asymptomatic carotid artery stenosis. Data from the study indicated that there were no deaths, major stroke or myocardial infarctions as a result of periprocedural or postprocedural interventions at at two years.
InspireMD said that the results were consistent with other CGuard EPS trials including the Carenet, Iron-Guard, Wissgott and Casana studies.
“We are excited to see Prof. Musialek’s report out on the long-term follow-up data from the Paradigm study, which represents the longest known clinical follow-up with any such carotid devices to date. This is just another piece of data that continues to reinforce the potential benefits of CGuard EPS. The 24 month follow-up data from this trial simply confirms the sustained long term benefit CGuard could provide to patients with carotid artery disease,” CEO James Barry said in a press release.