InspireMD Begins CARENET Trial of CGuard Embolic Protection System for CAS

March 19, 2014—InspireMD, Inc. (Tel Aviv, Israel) announced the enrollment of the first patient in the CARENET (Carotid Embolic Protection Study Using Micronet) study, a multicenter European clinical trial for the company’s CGuard carotid embolic protection system (EPS). The objective of the CARENET study is to evaluate the safety and efficacy of the CGuard system in the treatment of carotid lesions in consecutive patients suitable for carotid artery stenting (CAS).

According to the company, the CARENET clinical study is a multispecialty trial that is designed to provide data and evidence for the CGuard carotid EPS in order to better understand the complexities and challenges of patients who experience carotid artery disease. 

The CGuard system uses the same MicroNet technology featured on the company’s MGuard and MGuard Prime coronary embolic protection systems. InspireMD’s MicroNet technology is a single-fiber knitted mesh wrapped on an open-cell stent platform designed to trap debris that can travel downstream after a patient is treated with traditional stenting methods. This technology seeks to protect patients from plaque debris and blood clots breaking off and traveling distally in the arteries, which can lead to life-threatening strokes. The aperture of the MicroNet pore is only 150–180 microns, which maximizes protection against the potentially dangerous plaque and thrombus that are liberated during the procedure, noted the company.

In the InspireMD press release, Prof. Joachim Schofer, MD, commented, “I have treated many patients with carotid artery disease over the years, and I am excited to participate in the CARENET clinical trial using the unique CGuard embolic protection system. The small pore size of the MicroNet technology allows excellent blood flow while trapping potentially harmful plaque debris and thrombus. The CGuard technology provides an elegantly simple solution for embolic protection that has not been available in the past. I look forward to using this device with other sites throughout Europe in the CARENET trial to help treat my patients with carotid disease.” Prof. Schofer is with the Hamburg University Cardiovascular Center in Hamburg, Germany.