VANCOUVER, CANADA – January 21, 2016 – Evasc Neurovascular Enterprises ULC today announced that it has received Humanitarian Use Device (HUD) designation from the U.S. Food and Drug Administration (FDA) for its eCLIPs Bifurcation Remodeling System for the treatment of intracranial aneurysms at wide-neck bifurcations.
The HUD designation is the first step in obtaining a Humanitarian Device Exemption (HDE) for the eCLIPs system. An approved HDE would allow Evasc to market the eCLIPs system in the United States as a treatment for wide-neck bifurcation intracranial aneurysms at the basilar tip and carotid terminus.
HDE is an alternative pathway to the FDA Pre-Market Approval (PMA) application process. In order to be eligible for a HUD designation, a device must be designed to treat a condition that affects fewer than 4,000 individuals in the US per year. Once HUD designation has been granted, HDE approval may be granted if it is shown that the device does not expose patients to an unreasonable or significant risk, that the probable benefit of the device outweighs the risk of injury or illness from its use, and that there are no legally-marketed comparable devices.
“We are delighted to receive HUD designation, as this is the first major step in pursuing full regulatory approval for eCLIPs in the United States,” said Dr. Donald Ricci, President and Chief Executive Officer of Evasc.
In development since 2008, eCLIPs is a patented endovascular device designed to treat 95% of cerebral aneurysm cases and is currently targeted for use in challenging wide-neck bifurcations. eCLIPs combines the best properties of stents and diverters and can be used for coil retention and to enhance flow disruption. eCLIPs avoids dangerous entry into the dynamic, fragile environment of the aneurysm sac while protecting and providing a platform for endothelial growth across the bifurcation neck. To date, eCLIPs has been used to treat cerebral aneurysms in over 25 patients in Canada and Europe.
Evasc Neurovascular is a privately held medical device company focused on the development of disruptive endovascular treatments for cerebral aneurysms. Evasc received CE mark approval in 2014. Evasc is headquartered in Vancouver, Canada.
Evasc Neurovascular is on the web at www.evasc.com.
For more information, contact Scott Wilson at +1 (604) 742-3811, firstname.lastname@example.org.