Cerus Endovascular Receives FDA Breakthrough Device Designation for Contour Neurovascular System

February 11, 2021—Cerus Endovascular Ltd. announced that it has received the FDA’s Breakthrough Device designation for its Contour neurovascular system in the United States.

According to the company, the Contour device is indicated for the treatment of intracranial aneurysms. It is composed of a fine mesh braid and targets the neck of the aneurysm, away from the vulnerable dome. Additionally, the system is designed to be self-anchored for stability and resheathable for precise placement. 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.

In Cerus Endovascular’s announcement, Chief Compliance Officer Lori Adels, PhD, stated, “We look forward to working with United States 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.”

Dr. Adels continued, “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 commercialization strategy and decisions.”

Stephen Griffin, PhD, President of Cerus Endovascular, added, “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 [Dr. Adels]. We anticipate initiating our United States clinical trial, under an investigational device exemption, soon and will work aggressively to bring our already CE Mark-approved Contour technology to the United States market.”