InspireMD Enrolls and Treats First Patients at Ballad Health System in U.S. Registration C-Guardian Clinical Trial of CGuard EPS
Tel Aviv, Israel -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announces the initiation of enrollment and successful completion of the first cases of the Company’s U.S. registration C-Guardian trial of CGuard EPS.
The first patients, who were under the care of principal investigator, Chris Metzger, M.D., system chair of clinical research at Ballad Health System in Eastern Tennessee, were successfully implanted with the CGuard EPS stent device. These are the first of 315 patients who are expected to be enrolled in the trial and treated with CGuard EPS in the treatment of carotid artery stenosis in 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. “The wealth of clinical evidence and real-world experience outside the U.S. 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 U.S. We are thrilled to participate in such an important effort to bring next generation devices to the growing therapeutic effort of treating CAD.”
InspireMD CEO, Marvin Slosman, added, “This milestone marks the beginning of what we consider to be the next step in our journey of establishing CGuard EPS as the leading stent device for treatment of CAD and the transition from surgical intervention to endovascular therapy. The U.S. market has been a priority for our company and we believe that the C-Guardian trial will potentially pave the way to CGuard becoming available to physicians and their patients to realize the ongoing results from our current 33 served global markets. We are grateful to Dr. Metzger and the Ballad Health System for leading this effort and their commitment to advancing our collective goals to improve patient outcomes and stroke prevention.”
InspireMD Director, and renowned Cardiologist and Carotid expert, Dr. Gary Roubin, shared, “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 Carotid Artery Disease take another step with the potential of having CGuard available to the medical community in the U.S.”
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