Expanded 2-Year Results Reported From the PARADIGM Clinical Study of InspireMD's CGuard EPS
May 30, 2018—InspireMD announced that expanded 24-month follow-up results from the PARADIGM-Extend clinical study using the company's CGuard embolic protection system (EPS) were presented by Professor Piotr Musiałek, MD, at EuroPCR 2018, held May 21–25 in Paris, France.
According to the company, PARADIGM-Extend is the continuation of PARADIGM, an investigator-led clinical study evaluating the use of the CGuard EPS in patients with symptomatic or asymptomatic carotid artery stenosis with increased stroke risk. The latest results include 251 patients.
Overall cumulative data showed no major strokes in the periprocedural or postprocedural period up to 30 days (0%). There was one minor periprocedural stroke (0.4%) and one death (nondevice related) at 30 days (0.4%). These results are consistent with the earlier reported data in the first patient cohort of 101 patients, which was presented in December 2017. Importantly, there were no strokes or stroke-related deaths between 12 and 24 months, noted the company.
In the InspireMD announcement, Prof. Musialek commented, “The 24-month clinical and duplex ultrasound evidence is consistent with the unprecedented, sustained safety and cerebral embolism prevention efficacy of CGuard EPS in both symptomatic and asymptomatic patients with carotid stenosis.” Prof. Musialek is with the Department of Cardiac and Vascular Diseases, John Paul II Hospital in Kraków, Poland.
The company also advised that the duplex ultrasound data confirm normal vessel healing with the CGuard EPS device and show no indication of long-term in-stent restenosis. These results include a significant proportion of challenging patients who would have otherwise been treated with carotid endarterectomy. The findings are consistent with other CGuard EPS clinical trials including CARENET, IRON-GUARD, WISSGOTT, and CASANA.