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InspireMD Announces the Inclusion of its CGuard Carotid Stent in CREST-2 Trial Following FDA Approval of the Investigational Device Exemption Supplement Application
- CGuard™ Carotid Stent will now be a treatment option in the stenting plus medical therapy arm of the trial for patients - - CREST-2 Trial is sponsored by
About this update from Inspiremd Inc.
[{"type":"text","content":"- CGuard™ Carotid Stent will now be a treatment option in the stenting plus medical therapy arm of the trial for patients - - CREST-2 Trial is sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) and actively engaged at more than 140 study locations - TEL AVIV, Israel, Feb. 28, 2022 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), a global developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, today announced its CGuard Carotid Stent, utilizing its proprietary MicroNet mesh, will be included as a device option for stenting in the CREST-2 Trial. Following the approval of the Carotid Revascularization Endarterectomy or Stenting Trial (CREST-2) Investigational Device Exemption (IDE) supplement application from the U.S. Food and Drug Administration (FDA) last week, InspireMD will be evaluating strategic sites to enable expediated access. Marvin Slosman, Chief Executive Officer of InspireMD commented, \"This approval for use of CGuard EPS in a trial as significant as CREST-2 is proxy to the validation of our technology platform, contributing to this important work. The CREST-2 Trial is widely acknowledged as the most significant ongoing trial to scientifically investigate the optimal course of treatment to prevent stokes for asymptomatic patients with significant carotid disease. The opportunity to be a part of CREST-2 is a tremendous milestone for our company, and we look forward to CGuard playing an important role in the stenting results,\" Mr. Slosman added. The study first enrolled patients in 2014, as two parallel multi-center randomized, observer-blinded endpoint clinical trials with the purpose of being to determine the best way to prevent strokes in patients with high grade carotid stenosis but no stroke symptoms related to that blockage. The trial will enroll an estimated 2,480 participants which will remain in the study for 4 years following the start of intervention. “The CREST-2 Executive Committee is keenly focused on positioning the results of the trial to be relevant, actionable, and informative to contemporary practices,” said Dr. Thomas Brott, Principal Investigator of the NINDS sponsored trial. “Over the course of the trial we have continually introduced state of the art medical, pharmacological therapies...