A total of 30 patients have been enrolled in the multi-specialty (interventional cardiologists, interventional radiologists and vascular surgeons) trial at four sites across Europe.
InspireMD said that the acute procedural performance of the CGuard device was 100% successful for all of the 30 patients enrolled in the trial.
These patients will be followed up using traditional assessments post-procedure and at 30 days to include MACE (death, stroke, MI), and ipsilateral stroke (31 days to one year).
Diffusion weighted magnetic resonance imaging is also being done pre and post procedure and at 30 days, as well as ultrasound examination at 30 days and one year on every patient.
InspireMD president and CEO Alan Milinazzo said that the completion of the CGuard CARENET trial on schedule with 100% procedural success rate is an important milestone for the company.
"The initial results support our belief that the MicroNet technology may deliver life-saving benefits to patients with carotid artery disease and revolutionize the way the carotid stenting procedures are performed, Milinazzo added.
"We are looking forward to analyzing the data from the CARENET trial and sharing the results in mid-September at the upcoming TCT conference."
The CGuard carotid embolic protection system uses MicroNet technology, a single fiber knitted mesh wrapped on an open cell stent platform designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods.
The MicroNet pore aperture is 150-180 microns and maximizes protection against the potentially dangerous plaque and thrombus within the carotid artery.
