InspireMD’s CGuard EPS to Treat Carotid Artery Disease Evaluated in C-Guardian Trial in the United States

July 23, 2021—InspireMD, Inc. announced the initiation of enrollment and the successful completion of the first cases of the company’s United States C-Guardian trial of the company’s CGuard embolic prevention stent system (EPS) for the treatment of carotid artery disease (CAD) and stroke prevention.

The first patients in the study were treated under the care of principal investigator, Chris Metzger, MD, System Chair of Clinical Research at Ballad Health System in Kingsport, Tennessee. The patients were successfully implanted with the CGuard EPS stent device. On July 22, Ballad Health also announced and provided commentary on the successful trial initiation.

According to InspireMD, the trial is expected to enroll 315 patients who will be treated with the CGuard EPS. The trial will include symptomatic and asymptomatic patients undergoing carotid artery stenting.

“I believe that the initiation of this trial marks an important milestone for the potential approval of CGuard EPS and the potential of CGuard EPS in advancing the treatment of CAD and stroke prevention,” commented Dr. Metzger in the company’s press release. “The wealth of clinical evidence and real-world experience outside the United States in the approved served markets with CGuard, demonstrating positive outcomes for patients was very compelling, which drew us to lead this trial to advance the CGuard EPS in the United States. We are thrilled to participate in such an important effort to bring next-generation devices to the growing therapeutic effort of treating CAD.”

Additionally, Gary Roubin, MD, an internationally renowned expert and pioneer in the United States in coronary artery stenting, stated in the announcement, “I am thrilled to contribute to the realization of this important milestone for InspireMD and encouraged to see the many years of advancing the treatment of [CAD] take another step with the potential of having CGuard available to the medical community in the United States.” Dr. Roubin is from Cardiovascular Associates at Brookwood Baptist Health in Birmingham, Alabama, and a Director of InspireMD.