NSPR - InspireMD Announces Presentation of Positive One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial of CGuard at LINC 2024 | Benzinga
Data demonstrate lowest reported primary endpoint event rate of 1.95% through twelve months post-procedure for any carotid stent or embolic protection device pivotal trial
Study results to support a Premarket Approval (PMA) application to FDA in H2 2024
U.S. commercial launch of the CGuard™ Prime Carotid Stent System anticipated in H1 2025, if approved
TEL AVIV, Israel, and MIAMI, May 28, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NASDAQ:NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the presentation of positive one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis at this year's Leipzig Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany.
Marvin Slosman, chief executive officer of InspireMD, stated, "We are very pleased to have such a significant presence at this year's LINC conference, highlighted by a presentation of the primary endpoint results from our C-GUARDIANS clinical study. The independently adjudicated major adverse event rates through one-year are the lowest reported to date from any carotid stent or embolic protection device pivotal trial. With these data in-hand, we now have line of sight to a PMA application in the back half of this year, with preparation ongoing for a robust U.S. commercial launch in the first half of 2025, if approved. In addition to these results, we continue to be enthusiastic about our plans to introduce both CAS and TCAR solutions serving the broadest community of specialists serving the carotid revascularization market with the best implant in CGuard Prime."
Dr. Chris Metzger, M.D., System Vascular Chief at OhioHealth, and lead investigator of the C-GUARDIANS trial, stated, "We are very excited that the one-year carefully adjudicated C-GUARDIANS data confirm the extremely low rates of stoke, death, myocardial infarction, and target vessel revascularization in this prospective trial of high-carotid endarterectomy (CEA) risk patients with obstructive carotid disease, including 25% who were symptomatic. These data confirm the potential ‘neuroprotective properties' of this unique MicroNet technology, offering an outstanding front-line option to consider for each patient with obstructive carotid artery disease."
Presentation details:
| Title: |
| One-Year Follow-Up Results from the C-GUARDIANS Pivotal Trial of the CGuard™ Carotid Stent System |
| Presenter: |
| Dr. D. Christopher Metzger, System Vascular Chief, OhioHealth |
| Date/time: |
| Tuesday, May 28th at 2:53 pm CEST (8:53am EDT) |
Presentation Highlights:
- From July 2021 to June 2023, 316 patients were prospectively enrolled in this single-arm carotid artery stenting study ...