InspireMD Completes Trial of Carotid Embolic Protection System
InspireMD Tuesday announced completion of a clinical trial assessing the safety and efficacy of the CGuard system in the treatment of carotid lesions.
The CARENET (CARotid Embolic protection study using microNET) trial enrolled 30 patients at four European sites, with CGuard demonstrating 100 percent success in acute procedural performance.
The patients will be followed at 30 days for instances of major adverse cardiovascular events such as death, stroke and myocardial infarction and at for up to one year for ipsilateral stroke, the company said. InspireMD also is performing diffusion-weighted MRIs on each patient, post- procedure and at 30 days, along with ultrasound exams at 30 days and one year.
The findings will be presented at the Transcatheter Cardiovascular Therapeutics conference in September, InspireMD CEO Alan Milinazzo told Device Daily Bulletin.
CGuard uses the same MicroNet technology as the company’s MGuard and MGuard prime embolic protection stents — a single fiber-knitted mesh wrapped on an open cell stent. The technology traps debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods, leading to strokes.
InspireMD plans to conduct additional studies in the U.S. and international markets, but the near-term focus is European commercialization since the device is already CE-marked, Milinazzo said. — Kellen Owings
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