CARENET 30-Day Data Published for InspireMD's CGuard Carotid EPS

August 17, 2015—Prof. Joachim Schofer, MD, et al, who conducted the CARENET trial to evaluate the feasibility of the CGuard carotid embolic protective stent system (CGuard EPS, InspireMD, Inc.), published the 30-day findings in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2015;8:1229–1234).

The CGuard EPS, which features the company’s MicroNet technology, is a thin-strut nitinol stent combined with a polyethylene terephthalate mesh covering that is designed to prevent embolic events resulting from treatment of carotid artery lesions in patients suitable for carotid artery stenting (CAS). Prof. Schofer, who is the CARENET trial’s Principal Investigator, presented the 30-day data in September 2014 at the Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

In the study, a total of 30 consecutive patients meeting the conventional CAS inclusion criteria (ages, 71.6 ± 7.6 years; 63% men) were enrolled at four centers in Germany and Poland. Protection devices were used in all procedures.

The primary combined endpoint was the procedural success of the CGuard system and the number and volume of new lesions on the ipsilateral side assessed by diffusion-weighted MRI at 48-hours postprocedure and at 30 days. The secondary endpoint was 30-day major adverse cardiac or cerebrovascular events (death, stroke, or myocardial infarction). 

The investigators reported that procedure success was 100%, with 0% procedural complications. The 30-day major adverse cardiac or cerebrovascular events rate was 0%. New ipsilateral ischemic lesions at 48 hours occurred in 37% of patients, and the average lesion volume was 0.039 ± 0.08 cm³. The 30-day diffusion-weighted MRI showed complete resolution of all but one periprocedural lesion and only one new minor (0.116 cm³) lesion in relation to the 48-hour scan.

The investigators concluded that the use of the CGuard system in patients undergoing CAS is feasible and that the benefit of using CGuard may extend throughout the stent healing period.

The CGuard EPS has received European CE Mark approval. InspireMD announced on August 7 that it has entered into a partnership with Penumbra, Inc. to distribute the carotid CGuard EPS through Penumbra’s direct commercialization team in Europe and international markets. The device is not approved in the United States. In January 2015, CARENET Coprincipal Investigator Prof. Piotr Musialek, MD, presented the trial’s 6-month data at a late-breaking trial session at LINC 2015: the Leipzig Interventional Course in Leipzig, Germany.