Cerus Endovascular today said it has received FDA breakthrough device designation for its Contour Neurovascular System.
The Contour Neurovascular System is designed to treat intracranial aneurysms. It is made of fine mesh braid to target the neck of the aneurysm away from the vulnerable dome. It can be self-anchored for stability, is re-sheathable for precise placement and the sizing criteria are less restrictive because of its deployment across the neck.
“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. Lori Adels, Chief Compliance Officer,” president Stephen Griffin said in a news release. “We anticipate initiating our U.S. clinical trial, under an Investigational Device Exemption, soon and will work aggressively to bring our already CE Mark-approved Contour technology to the U.S. market.”
The FDA issues breakthrough device designations to medical devices that have the potential for a more effective treatment option for life-threatening or irreversibly debilitating diseases. The designation helps expedite the traditional development assessment and review process to allow medical professionals to get access to new developments quicker.
“We look forward to working with U.S. 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,” Adels said. “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.”