Cerus Endovascular Receives FDA Approval

Cerus Endovascular has announced that it has received the FDA investigational device exemption for a trial for its Contour Neurovascular System. Cerus is based in Fremont, California and its Contours is designed to treat intracranial aneurysms. It has been created with a fine mesh braid to target the neck of the aneurysm away from the vulnerable dome.

The system for stability cannot be self-anchored. It is re-sheathable for precise placement and the criteria for sizing is less restrictive due to the deployment across the neck. FDA breakthrough is received device designation in February this year. The news release studied the design to produce the data set for supporting the safety and efficacy of the Contour Neurovascular System.

It has been embolization of wide-necked, bifurcated, saccular intracranial aneurysms. The company intends to submit results in a premarket approval application to the FDA. Cerus Endovascular president, Stephen Griffin, said in the release, “We are eager to move ahead with this important trial and anticipate patient enrollment beginning within the next three months. The IDE study protocol closely aligns with protocols of other intra-saccular aneurysm repair devices that have received FDA approval. Given the real-world patient outcomes we have experienced in Europe, where the Contour Neurovascular System™ has had CE mark approval since March 2020, we are hopeful that we will see similar, strong results from this trial.”

They say that they have ahead of the important trial as they want to be patient with the enrolment of beginning within the upcoming months.