InspireMD Announces Publication of Meta-Analysis Citing Benefits of Next Generation Mesh-Covered Carotid Stent Systems
InspireMD ($NSPR) recently announced the publication of a meta-analysis of four clinical studies involving dual layered and mesh-covered stents in the December 10, 2018 issue of JACC: Cardiovascular Interventions.
The analysis concluded that carotid artery disease (CAD) patients treated with mesh-covered stents experienced a 30-day minor stroke rate of 1.25%, lower than 30-day minor stroke rates reported in other widely cited studies, such as CREST and ACT 1, for patients treated with both carotid endarterectomy (CEA) and with those treated with conventional carotid stents. Moreover, CREST and ACT 1 involved lower-risk patient populations as compared to the four studies included in the meta-analysis, which included a higher percentage of high-risk and elderly patients.
“The compelling results of this independent and comprehensive meta-analysis, which includes four studies of high-risk patients treated for carotid artery disease, add to the growing body of evidence that points to superior clinical outcomes with next generation mesh-covered or dual layered devices versus their conventional carotid stent counterparts,” said James Barry, PhD, Chief Executive Officer of InspireMD. “As we continue to expand the commercial availability of our MicroNet-covered product, CGuard EPS, including the submission of a U.S. IDE expected in mid-2019, we welcome additional analyses such as these that further support the positive findings from our own studies with MicroNet-covered products.”
This paper is also the focus of a follow-up article, dated December 12, 2018, that appeared in the publication Medcape along with a discussion with a leading European interventional cardiologist, Professor Harald Mudra, MD, Städtisches Klinikum, Munich, Germany, who commented, “I think we are seeing a new milestone with these mesh-covered stents in that we can achieve a very acceptable, low rate of complications and stroke even in high-risk patients. If confirmed in larger and longer trials, these stents could open up a new population for carotid stenting who have previously been thought of as being too high risk for the procedure.”
“We now only use these mesh-covered stents at our center. I am convinced they are superior to conventional carotid stents. The extra layer of mesh keeps the small particles of plaque that can be released during the stenting process from entering the circulation,” Prof. Mudra added.
The full JACC paper can be purchased online here.