Wide-neck bifurcations in cerebral aneurysms are among the most difficult to treat. Vancouver start up Evasc Neurovascular Enterprises ULC has developed the Eclips Aneurysm Remodeling System; it's expected to offer a potential new standard-of-care, particularly in wide-neck bifurcations.
Better aneurysm option?
The company has just secured a C$10 million ($7.5 million) series A financing that it expects will be sufficient to continue an ongoing European trial, to conduct a French trial aimed at reimbursement and to start an FDA IDE trial in early 2018. It also plans to update the current device with the funds, as well as to modify it for related indications.
The Eclips device already has a CE mark and is available for emergency use in Canada and the U.S. under, respectively, Health Canada's Special Access Program and the Humanitarian Use Device designation.
"The device came out of the need to retain coils in wide-neck terminal aneurysms that had a bifurcation. The need arose because in the early days and still to the present time clamping coils at a wide neck doesn't give enough of a rim at the neck to hold the neck in place, they need something to help retain them," Evasc co-founder and CEO Donald Ricci told BioWorld MedTech.
"So, initially the Eclips device was developed as a coil retaining device, but we soon discovered it could act as a flow diverting device and as a platform for endothelial growth across the neck of the aneurysm," he added.
The device is designed to treat 95 percent of cerebral aneurysm, with an initial targeting specifically for wide-neck bifurcations. It can be used for coil retention after coil embolization, a minimally invasive procedure that treats the aneurysm by filling it with material that closes of the sac and lowers the risk of rupture or rebleed.
Flow diversion is typically done to treat an unruptured cerebral aneurysm; it's accomplished by placing a device inside the aneurysm sac, as is done with coils, in the parent blood vessel to divert blood flow away from the aneurysm.
Ricci sees the combination of the coil-retaining property with flow diversion of the aneurysm to the side branches, thereby avoiding the water-hammer effect that compresses other coils and interceptor devices, as key to the advantages of Eclips.
In the clinic
An ongoing European clinical trial of the device, known as the European Eclips Safety, Feasibility and Efficacy Study (EESIS), is enrolling patients at about seven or eight sites now, next Evasc will start a French trial aimed at securing reimbursement in that country and a pivotal U.S. trial to eventually secure FDA approval.
The U.S. trial is slated to be a single-arm trial, so it will not seek to demonstrate superiority. But Ricci sees that data emerging in the over 40 treatment cases thus far in Europe and Canada with the device.
"It offers proof-of-principle in that we do have the kind of results that we expected that we would get, in that there has been no persistent aneurysm or recurring aneurysm in the follow-up cases we have to date. Those cases have allowed us to do a measure of superiority," said Ricci.
In addition to the trials, Evasc plans to use the new infusion of funds to modify the device for additional potential applications such as in other anatomic territories in smaller vessels, as well as for use in tortuous anterior circulation and for sidewall applications. The Eclips device itself will also be updated to simplify deployment and improve accessibility for interventionists.
The spine-rib device design offers self-aligning delivery; it is also retractable and repositionable with an anchor segment that prevents migration. Eclips works over any 0.014-inch guide wire and does not shorten after deployment. Its dense rib structure offers coverage of about 30 percent across the neck.
Evasc has raised a total of C$27 million via seed rounds to develop and commercialize the Eclips System. The series A round was led by Yonghua Investment Management Co. Ltd. of Shanghai, a subsidiary of the Yongjin Group that focuses on high-tech investment, with a participation from the existing investors.
"This new funding will allow us to accelerate our plans to transform the cerebral aneurysm repair industry, enabling a much higher level of patient care and successful treatment outcomes than is currently possible," said Ricci.