Preliminary 3-Year Data From PARADIGM-Extend Trial Evaluate InspireMD's CGuard EPS
September 27, 2018—InspireMD, Inc. announced that findings from the PARADIGM-Extend trial of the company's CGuard MicroNet-covered embolic prevention system (EPS) were presented in a poster at TCT 2018, the Transcatheter Cardiovascular Therapeutics annual scientific symposium held September 21–25 in San Diego, California. Preliminary cumulative 3-year follow-up safety, efficacy, and stroke prevention durability data were presented at TCT.
PARADIGM-Extend is the continuation of PARADIGM, an investigator-led clinical study evaluating the use of the company's CGuard EPS in patients with symptomatic or asymptomatic carotid artery stenosis with increased stroke risk.
According to the company, overall cumulative data showed no stroke or stroke-related deaths between 24 and 36 months and the absence of any device-related issues in the first 93 of the 251 patients in the PARADIGM-Extend cohort.
Lead Investigator Professor Piotr Musiałek, MD, commented in InspireMD's announcement, “These preliminary 3-year follow-up data continue to show very compelling safety, stroke prevention efficacy and long-term durability of CGuard EPS in an all-comer symptomatic and asymptomatic carotid artery stenosis patient population with various stages of disease progression. The risk of stroke and other serious complications postprocedure remains a significant consideration in the treatment of carotid artery stenosis, and these results reflect the sustained, long term potential of CGuard EPS to significantly improve patient outcomes and evolve into the new standard of care.” Prof. Musialek is with Department of Cardiac and Vascular Diseases at John Paul II Hospital in Kraków, Poland.
The company advised that 2-year follow-up data on 251 patients from PARADIGM-Extend were reported at EuroPCR 2018, held May 21–25 in Paris, France. Additional 3-year data from PARADIGM-Extend will be presented at the 45th annual VEITHsymposium, held on November 13–17 in New York, New York.