Cerus Endovascular has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Contour Neurovascular System.
The Contour Neurovascular System is indicated for the treatment of intracranial aneurysms. The company states that the product is composed of fine mesh braid and represents a unique intrasaccular advancement in the market, as it targets the neck of the aneurysm, away from the vulnerable dome.
Cerus Endovascular further claim that the System is designed to be self-anchored for stability, re-sheathable for precise placement, and because it is deployed across the neck, sizing criteria are less restrictive than other commercially available intrasaccular devices, making it easier to use in the clinical setting.
“Today’s news marks another significant milestone in our company’s evolution and is the direct result of the commitment and strength of our scientific team, led by Lori Adels, chief compliance officer,” stated Stephen Griffin (Fremont, USA), president of Cerus Endovascular. “We anticipate initiating our US clinical trial, under an Investigational Device Exemption, soon and will work aggressively to bring our already CE mark-approved Contour technology to the US market.”
“We look forward to working with US regulatory authorities to expedite the availability of this innovative device that could provide an effective, minimally invasive treatment for bifurcated, intracranial aneurysms, a life threatening condition,” noted Adels. “Under this program, the FDA will provide us with timely, interactive communication, priority review and FDA senior management engagement regarding the development of efficient and flexible clinical trial protocols, through to commercialisation strategy and decisions.”