Evasc Neurovascular’s eClips Device Studied for Safety, Feasibility, and Efficacy in France

January 13, 2022—Evasc Neurovascular announced the enrollment of the first patient in EESIS-FR, the French safety, feasibility, and efficacy study of the company’s eClips device.

EEIS-FR will enroll patients at up to 28 neurointerventional sites in France. The objective of the study is to evaluate the technical feasibility, safety, and efficacy of the eClips devices for the treatment of bifurcation aneurysms.

According to the company, the procedural success of the second-generation eClips bifurcation remodeling system will be evaluated to determine its feasibility. Safety will be measured by major stroke or death within 30 days or major territorial stroke or neurological death within 1 year. Additional endpoints will be evaluated and data collected to assess procedural success and collect efficacy information on the other eClips products.

Raphael Blanc, MD, is Principal Investigator of the study. Dr. Blanc is a consultant interventional neuroradiologist and Deputy Head of the Department of Interventional Neuroradiology at Rothschild Foundation Hospital in Paris, France.

“I am pleased to have enrolled the first patient in this important clinical study to help further the clinical understanding of the real-world effectiveness of the second-generation eClips aneurysm treatment system,” commented Dr. Blanc in the Evasc press release. “We have seen an enormous improvement in the second-generation eClips delivery system: stability and placement within 8 minutes is a game-changer in the neurointerventional practice.”

Evasc Neurovascular noted that eClips is a nontubular endovascular device currently targeted for use in challenging wide-neck bifurcations. eClips uses technology designed to treat 95% of cerebral aneurysm cases. The eClips design provides coil retention and flow diversion at the neck. eClips avoids entry into the aneurysm sac while leaving side branches unencumbered and provides a platform for endothelial growth across the bifurcation neck.

The eClips device has been granted “innovative” status in the French Forfait Innovation program. The study is partially funded by the French National Authority for Health within this program, advised eVasc Neurovascular.