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Wednesday, May 17, 2017 8:56:09 AM
https://finance.yahoo.com/news/inspiremd-announces-publication-iron-guard-124500356.html
InspireMD Announces Publication of the IRON-GUARD Registry in EuroIntervention
[Accesswire]
AccesswireMay 17, 2017
Zero incidence of major adverse cardiovascular events including no major strokes
BOSTON, MA / ACCESSWIRE / May 17, 2017 / InspireMD, Inc. (NYSE MKT: NSPR) (NYSE MKT: NSPR.WS) ("InspireMD" or the "Company"), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced the publication of the Investigator Initiated IRON-GUARD Italian clinical registry in the peer reviewed journal EuroIntervention, which appeared in the May 9th issue. IRON-GUARD was an independent, multicentre, multi-disciplinary clinical study treating patients with carotid artery disease using the CGuardTM EPS (embolic prevention system) in 12 Italian centers.
The IRON-GUARD registry enrolled 200 patients, and showed results of 100% technical success placing the device, and zero incidence of major adverse cardiovascular events (MACE), comprised of death, major stroke or myocardial infarction, in all patients at 30 days. Five (2.5%) minor strokes and two transient ischemic attacks (1%) were observed, which were resolved by 30 days.
Study authors included Professor Carlo Setacci, MD, Francesco Spezialie, MD; Laura Capoccia, MD; Pasqualino Sirignano, MD; Wassim Mansour, MD: Chiara Pranteda, MD; and Renato Casana, MD.
Dr. Francesco Spezialie, stated, "In our multi-center, multi-specialty experience, use of the CGuard EPS in routine clinical practice was associated with no major peri-procedural neurologic complications and a total elimination of post-procedural neurologic complications after 30 days. The CGuard EPS has shown itself to be a promising treatment for carotid lesions."
James Barry, PhD, Chief Executive Officer of InspireMD, commented, "We were pleased to see the results of the IRON-GUARD registry accepted and published in EuroIntervention. These results further validate the positive clinical outcomes of other trials and registries utilizing CGuardTM EPS and the data is quite consistent with those other clinical trials. To our knowledge, this now appears to be the largest registry utilizing CGuard. Following on from the very successful Paradigm 101 study, IRON-GUARD is a further high quality independent registry which continues to give us confidence in CGuard becoming the standard-of-care for treatment of carotid artery disease due to the significant safety advantages of our device."
EuroIntervention is a monthly peer-reviewed journal of interventional cardiovascular medicine that has become one of the benchmarks in its field. EuroIntervention is the official journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI). The Journal is endorsed by the European Society of Cardiology (ESC) and has a distinguished European and International editorial board led by Prof Patrick W. Serruys from the Erasmus MC, Rotterdam.
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