Cerus Endovascular Receives FDA Breakthrough Designation for Intracranial Aneurysm System
Cerus Endovascular has obtained the FDA’s breakthrough device designation for the Contour Neurovascular System, a device cleared in Europe for treating intracranial aneurysms.
The Contour system is made of a fine mesh braid with shape memory properties that is deployed across the neck of the aneurism sac. The mesh is self-anchoring and re-sheathable for accurate placement.
Cerus said it intends to launch a U.S. clinical trial under an investigational device exemption and will “work aggressively” to get the device to the American market.