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InspireMD Engages Hart Clinical Consultants to Conduct Clinical Trial for CGuard Carotid Stent System in the United States
TEL AVIV, Israel, Feb. 24, 2021 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the
About this update from Inspiremd Inc.
[{"type":"text","content":"TEL AVIV, Israel, Feb. 24, 2021 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, announced today that it has engaged Hart Clinical Consultants (HCC), a leading Contract Research Organization (CRO) to conduct the clinical trial for its CGuard Carotid Stent System in the United States. “HCC is ideally suited to manage this trial having supported clinical trial operations for a variety of products and indications, including with multiple carotid intervention procedures,” stated Marvin Slosman, InspireMD’s CEO. “This is an important step in our goal to achieve commercial registration of the CGuard System in the United States, one of the largest and most important markets for the sale and distribution of our device. This will be the first U.S.-based study of CGuard and our opportunity to demonstrate its potential for the prevention of stroke caused by carotid artery disease in patients in the United States. Now that we have also identified our stellar lead investigator in Dr. Chris Metzger and closed a $20.7 million public offering, which provides the company the financial resources needed to complete the trial, we believe that we are well positioned to continue to execute on our global expansion strategy.” “We look forward to working with InspireMD on this pivotal trial of the CGuard System to help establish a new standard of care for the management of carotid artery disease and stroke prevention. We differentiate our organization from other CRO’s in that our staff has either direct interventional cath lab or cardio-thoracic operating room experience. This allows us to function extremely well in technical areas when carrying out clinical trial operations or conducting device training,” said Jim Hart, CEO of HCC. About the CGuard® EPS The CGuard® Embolic Protection System is an advanced platform solution designed to deliver the flexibility of the traditional open-cell stent with advanced protection from peri-procedural and post-procedural embolic events caused by plaque prolapse through the stent strut that can lead to stroke. CGuard’s unique MicroNet® technology mitigates the prolapse and associated embolization and has shown superior clinical outcomes for patients against alternative carotid stent types,...