Preliminary 2-Year PARADIGM 101 Results Presented for InspireMD's CGuard EPS
December 5, 2017—InspireMD announced the preliminary 24-month follow-up results from the PARADIGM 101 clinical study utilizing the company's CGuard embolic protection system (EPS).
The long-term follow-up data were presented by Piotr Musialek, MD, at the 2017 VEITHsymposium in New York, New York on November 16 and the ICI Meeting 2017 in Tel Aviv, Israel on December 4. Dr. Musiałek is with the Department of Cardiac and Vascular Diseases at John Paul II Hospital in Kraków, Poland.
PARADIGM 101 is an investigator-led clinical study evaluating the use of the CGuard EPS in 101 consecutive all-comer patients with symptomatic or high-risk asymptomatic carotid artery stenosis. The data presented illustrated that no periprocedural or postprocedural intervention-related death, major stroke, or myocardial infarction had occurred in the study patients at 24-month follow-up.
According to the company, the results in PARADIGM 101 are consistent with the other CGuard EPS trials, including CARENET, IRON-GUARD, WISSGOTT, and CASANA. The long-term preliminary results from PARADIGM 101 further confirm the sustained benefits of CGuard out to 2 years and make it a potential permanent therapeutic protection option for all-comer patients with carotid artery disease.