September 3, 2020
Thirty-Day Data Presented From PARADIGM-EXTEND Study of InspireMD’s CGuard EPS Device
September 3, 2020—InspireMD, Inc. announced the presentation of updated data from the large, long-term PARADIGM-EXTEND study of the company’s CGuard embolic prevention system (EPS), as part of the European Society of Cardiology (ESC) 2020 Carotid Update e-presentation at ESC Congress 2020—The Digital Experience, held online as a virtual event August 29 to September 1, 2020. The presentation won the award for Best ESC Congress Poster, noted the company.
PARADIGM-EXTEND is an investigator-driven on-going study performed with InspireMD’s CGuard carotid stent for primary and secondary stroke prevention in a large, consecutive all-comers population, with 5 years (60 months) follow-up.
At ESC, results from 480 patients who completed 30-day follow-up in PARADIGM-EXTEND were presented by lead investigator Professor Piotr Musialek, MD, of Jagiellonian University Department of Cardiac & Vascular Diseases John Paul II Hospital, Kraków, Poland.
According to InspireMD, there were no periprocedural major strokes or death. The total death/stroke/myocardial incidence at 30 days was 1.04% (5/480) with two minor strokes, one myocardial infarction, and two stent-unrelated deaths. In the study, 354/480 patients completed the 12-month follow-up with only one patient experiencing in-stent restenosis, 0.28% (1/354). At the 12-month follow-up, there were no other device-related adverse clinical events. Finally, 46/480 patients completed the 60-month follow-up period with one more case of in-stent restenosis and no additional cases of device-related stroke.
In the company’s press release, Prof. Musialek stated, “In consecutive all-comer patients, CGuard EPS stent nearly abolished, in an unprecedented magnitude, stroke risk in relation to carotid restenosis. Based on the PARADIGM-EXTEND and other accumulated clinical data on CGuard’s safety and efficacy, in our ESC 2020 Carotid Update Lecture, we indicated that increasing the use of the MicroNet-covered stent demonstrates a fundamental change in the carotid revascularization paradigm, with significantly larger proportions of patients now able to benefit from this technology and a percutaneous procedure rather than surgery.”