InspireMD Announces Study on Clinical Benefit and Utility of the CGuard EPS

 

October 19, 2016—InspireMD, Inc. announced the publication of positive 6-month clinical results on the company’s carotid CGuard double-layered embolic prevention stent (EPS) in patients with symptomatic or high-grade asymptomatic internal carotid artery (ICA) stenosis. The study by Prof. Christian Wissgott, MD, et al is available online ahead of print in Journal of Endovascular Therapy (JEVT).

According to the company, the study independently evaluated the CGuard device versus other carotid stents and conducted a study in 30 consecutive patients with ICA disease. The average stenosis of the treated arteries was 84%, with a mean lesion length of 17 mm. The majority of the patients (83%) had symptomatic disease. Patients were followed for 6 months postprocedure and were assessed using a number of variables, including stroke, change in modified Rankin scale (mRS) score, CGuard EPS patency, and new ipsilateral lesions as measured by diffusion-weighted magnetic resonance imaging (DW-MRI). 

The investigators reported 100% success in implanting the CGuard EPS, with no peri- or postprocedural complications. At 6-month follow-up, there were no deaths, major adverse events, minor or major strokes, or new neurologic symptoms; additionally, the mRS score improved for the symptomatic patients from 1.56 before to 0 after the procedure. All vessels treated with the CGuard system remained patent at 6 months. DW-MRI performed in 19 of 30 patients found no new ipsilateral lesions after 30 days and after 6 months compared with the baseline DW-MRI studies.

The study also found that based on engineering evaluations, the CGuard EPS provides a high radial force and strong support in stenotic lesions and that its structure adapted well to changes in vessel diameter and direction. The MicroNet mesh of the CGuard did not cause any changes to specific mechanical parameters of the underlying stent.

As quoted in InspireMD’s announcement, Prof. Wissgott stated, “The novel construction of the CGuard EPS prevented postprocedural embolic events in this series of patients undergoing routine carotid artery stenting.” He added, “The CGuard EPS is easy and safe to implant because it more readily adapts to the shape and diameter of the vessel wall versus other carotid artery stents. Importantly, none of the patients in this series experienced any complications or strokes as a result of the procedure or in the following 6 months. Consequently, I believe that the CGuard EPS is an important new treatment option for both symptomatic and asymptomatic carotid artery stenosis patients.”

InspireMD also advised that an editorial in JEVT entitled, “Carotid Artery Revascularization for Stroke Prevention: A New Era,” by Prof. Piotr Musialek, MD, and Silke Hopf-Jensen, MD, underscores the use of CGuard EPS as a novel approach to potentially reducing the risk of stroke by avoiding the risks associated with conventional carotid stenting.

As summarized by InspireMD, Prof. Musialek and Dr. Hopf-Jensen stated that 85% of strokes occur without warning signs, raising questions about the validity of “watchful waiting” in patients with asymptomatic carotid artery stenosis. They added that novel stent technology ensures the viability of endovascular approaches to carotid revascularization in both primary and secondary stroke prevention. They also advised that consistent clinical evidence is accumulating that demonstrates that mesh-covered stents, particularly the CGuard EPS, prevent postprocedural embolic events. The data presented by Prof. Wissgott et al is consistent with the positive outcomes reported in all other clinical trials of CGuard, stated Prof. Musialek and Dr. Hopf-Jensen.

Prof. Musialek and Dr. Hopf-Jensen stated, “Given the risks associated with prior carotid stent options to date, many physicians prefer to treat their asymptomatic patients with medication only, rather than medication plus interventional plaque pacification. The growing body of data for the CGuard EPS demonstrates that this novel system may have a much lower risk of peri- or postprocedural complications and embolic events. Prof. Wissgott’s study and the results of the CARENET and PARADIGM 101 studies demonstrate that CGuard EPS may help to reduce the risk of stroke for asymptomatic patients and provide them with improved long-term cerebrovascular outcomes. There is little to no doubt today that a new carotid revascularization era has arrived.” 

 

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