The system is designed for the endovascular embolisation of wide-necked, bifurcated, saccular intracranial aneurysms
Cerus Endovascular has secured an approval from the Food and Drug Administration (FDA) to conduct a clinical trial for the Contour Neurovascular System in the US.
In February, the system received breakthrough device designation from the FDA.
The clinical study will be carried to develop a robust data set to support the safety and efficacy of the Contour Neurovascular System.
The system is designed for the endovascular embolisation of wide-necked, bifurcated, saccular intracranial aneurysms.
Cerus Endovascular will submit the study results in a Premarket Approval (PMA) application to the FDA.
Cerus Endovascular president Stephen Griffin said: “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.”
Featuring fine mesh braid, the Contour Neurovascular System is developed to target the neck of the aneurysm, away from the vulnerable dome.
The company said that the system is designed to be self-anchored for stability, re-sheathable for precise placement.
As it is deployed across the neck, the system facilitates less restrictive sizing criteria compared to other commercially available intrasaccular devices, the firm said.
The Contour Neurovascular System secured CE Mark approval in February last year.
Cerus Endovascular is engaged in the development of interventional neuroradiology devices and delivery systems for the treatment of acute, life-threatening neurological conditions.
The flow diverter is designed to treat intracranial aneurysms and a range of morphologies, including wide-necked bifurcation and bifurcation aneurysms.