Home » Cerus Endovascular Receives FDA Breakthrough Designation for Intracranial Aneurysm System
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.
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