The study, partially funded by the French National Authority for Health (HAS), is designed to evaluate the technical feasibility, safety, and efficacy data of eCLIPs products in treating bifurcation aneurysms
Canadian medical equipment manufacturer Evasc Neurovascular has enrolled first patients in the safety, feasibility and efficacy study of its eCLIPs products (EESIS-FR) in France.
The study is partially funded by the French National Authority for Health (HAS), within the Forfait Innovation programme and will enrol patients at up to 28 sites throughout France.
It is designed to evaluate the technical feasibility, safety, and efficacy of the eCLIPs products for the treatment of bifurcation aneurysms.
Evasc Neurovascular president and chief executive officer Donald Ricci said: “Thanks to our French partners, we have achieved this significant milestone after many years of hard work.”
The study is structured to evaluate the second generation eCLIPs Bifurcation Remodelling System to determine its feasibility and safety, measured as of a major stroke or death within 30 days, or major territorial stroke or death within one year.
It will involve evaluation of additional endpoints and collection of efficacy information on the other eCLIPs products, said Evasc.
The study principal investigator Raphael Blanc said: “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.
“We have seen an enormous improvement in the second generation eCLIPs delivery system: stability and placement within eight minutes is a game-changer in the neurointerventional practise.”
According to the company, eCLIPs is a non-tubular endovascular device designed for use in a challenging wide-neck bifurcations, and offers coil retention as well as flow diversion at the neck.
The device leverages technology that is designed to treat 95% of cerebral aneurysm cases.
Also, eCLIPs prevents unsafe entry into the dynamic, fragile environment of the aneurysm sac, while facilitating endothelial growth across the bifurcation neck, said the company.
Based in Vancouver, Canada, Evasc Neurovascular is focused on development of advanced endovascular treatments for cerebral aneurysms.
In October last year, the company has unveiled the third generation of its eCLIPs device, the eCLIPs Bifurcation Flow Diverter.