Evasc Neurovascular announces the recruitment of the first patient in the French eCLIPs ™ safety, feasibility and efficacy study (EESIS-FR)
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The objective of this study is to obtain data on the technical feasibility, safety and efficacy of second generation eCLIPs products for the treatment of bifurcation aneurysms.
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VANCOUVER, British Columbia – Evasc Neurovascular, a pioneer in the development of endovascular disruptive therapies for cerebral aneurysms, today announced the recruitment of the first patient in its French eCLIPs ™ study on safety, feasibility and efficacy ( EESIS-FR). The study will be conducted in France with the aim of evaluating the technical feasibility, safety and efficacy of eCLIPs products for the treatment of bifurcation aneurysms. The eCLIPs system has obtained “innovative” status in the French Forfait Innovation program and the study is partially funded by the Haute Autorité de Santé (HAS) within the framework of this program. Up to 28 neuro-interventional sites in France will recruit patients in this study.
The success of the eCLIPs Second Generation Bifurcation Remodeling System procedure will be evaluated to determine its feasibility and its safety will be measured based on a major stroke or death within 30 days, or a Major territorial stroke or neurological death within one year. Additional evaluation criteria will be assessed and data collected to assess the success of the procedure and to collect information on the effectiveness of other eCLIPs products.
“I am delighted to have enrolled the first patient in this important clinical study to help better understand the real-world effectiveness of the eCLIPs Second Generation Aneurysm Treatment System. We have seen a huge improvement in the second generation eCLIP delivery system: stability and placement within eight minutes is a game-changer in neurointerventional practice, ”said Dr. Raphael Blanc, study principal investigator and consultant. in interventional neuroradiology and deputy head of the interventional neuroradiology service at the Rothschild Foundation hospital, Paris, France.
“Thanks to our French partners, we have taken this important step after many years of hard work,” said Dr. Donald Ricci, President and CEO of Evasc Neurovascular.
About the eCLIPs Aneurysm Treatment System
eCLIPs is a non-tubular endovascular device currently intended for use in difficult wide neck bifurcations, using technology designed to treat 95% of cases of cerebral aneurysm. The unique design of the eCLIPs allows not only coil retention, but also flow deflection at the neck. eCLIPs prevents dangerous entry into the dynamic and fragile environment of the aneurysm sac while leaving the lateral branches free and providing a platform for endothelial growth through the bifurcation neck.
Evasc Neurovascular is a privately held medical device company focused on the development of endovascular disruptive treatments for cerebral aneurysms. Evasc Neurovascular is headquartered in Vancouver, Canada. For more information, please visit evasc.com.
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