Cerus Endovascular announced today that it received FDA investigational device exemption for a trial for its Contour Neurovascular System.
Fremont, Calif.–based Cerus’ Contour Neurovascular System is designed to treat intracranial aneurysms. Its creators made it of fine mesh braid to target the neck of the aneurysm away from the vulnerable dome.
It’s possible to self-anchor the system for stability. It’s re-sheathable for precise placement, and the sizing criteria are less restrictive because of its deployment across the neck. It received FDA breakthrough device designation in February of this year.
According to a news release, the study is designed to produce a data set that will support the safety and efficacy of the Contour Neurovascular System for the endovascular embolization of wide-necked, bifurcated, saccular intracranial aneurysms. Cerus intends to submit results in a premarket approval application to the FDA.
“We are eager to move ahead with this important trial and anticipate patient enrollment beginning within the next three months,” Cerus Endovascular president Stephen Griffin said in the release. “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.”