InspireMD and Jacobs Institute to Conduct EFS of CGuard EPS in Acute Stroke Patients With Tandem Lesions

November 27, 2023—InspireMD, Inc., developer of the CGuard embolic prevention system (EPS) for the prevention of stroke, announced that the company has entered into a strategic agreement with the Jacobs Institute at the State University of New York at Buffalo, and Adnan Siddiqui, MD, Vice-Chairman and Professor of Neurosurgery, to execute an early feasibility study (EFS) evaluating the safety and feasibility of the CGuard EPS carotid stent to treat severe carotid stenosis or occlusion in conjunction with thrombectomy in patients presenting with acute ischemic stroke and tandem lesions.

According to the company, the EFS is expected to enroll 15 patients at three sites in the United States.

“Tandem strokes with occlusion of both cervical and intracranial vessels are very common (~20%),” commented Dr. Siddiqui in the InspireMD press release. “To date, all clinical trials conducted in the United States for acute stroke from large vessel occlusions have specifically excluded them, resulting in a lack of guidelines and resultant great variability in the management of these lesions. As a result, there are currently no FDA-approved stents for this specific indication.”

Dr. Siddiqui continued, “The most dramatic part is that trials conducted outside the United States have shown [that] the value of thrombectomy in this patient population is the most beneficial of any large vessel occlusion category. Retrospective analyses from large centers across the globe have suggested the safety and efficacy of stenting in conjunction with intracranial thrombectomy. There is strong evidence to suggest that stenting in these lesions is superior to not stenting.”

He stated further, “I am delighted that InspireMD, with its C-Guard device, which has low metal surface area and therefore reduces thrombotic risk, as well as a MicroNet mesh that protects plaque prolapse intra- and postprocedure, have elected to investigate this critical indication. I am also excited that this brings the carotid disease as it pertains to neurointerventionalists to the forefront.”

“This EFS will help lead to a design of the pivotal trial that can bring this large, neglected population into the standard practice of revascularization for stroke,” concluded Dr. Siddiqui in the press release.

Marvin Slosman, Chief Executive Officer of InspireMD, added, “This EFS provides the appropriate platform for our investment in this indication to address carotid lesions in acute stroke settings and reinforces our commitment to the neuro community, as we aim to demonstrate that CGuard EPS is optimally designed with a low metal surface and MicroNet mesh covering for superior embolic protection during these acute events. We look forward to results from this study and view the tandem lesion indication as a critical component of our long-term growth strategy for the CGuard stent platform.”