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Cerus Endovascular’s investigational device exemption (IDE) application receives approval from the US Food and Drug Administration (FDA) to go ahead with a trail of its Contour Neurovascular System in the US. The system has been developed for treating intracranial aneurysms, specifically the endovascular treatment of wide neck aneurysms.
An aneurysm is an abnormal focal dilatation of an artery. The trial aims to obtain a strong data set that would prove the safety and effectiveness of the Contour Neurovascular System for the endovascular embolisation of wide-necked, bifurcated and saccular intracranial aneurysms.
Cerus Endovascular president Dr Stephen Griffin shared in a statement:
We are eager to move ahead with this important trial and anticipate patient enrolment 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.
After the trail, the company will forward the results to the FDA to clear the system for market.
The news comes after Cerus Endovascular obtained CE mark approval for the system to treat saccular intracranial aneurysms back in March 2020.
Cerus Endovascular chairman Dr Sam Milstein said in a statement:
Since obtaining CE Mark last year, we have completed cases in 121 new partner institutions within 12 countries across Europe and Asia.
During this time, we have accumulated substantial additional clinical data as well as 12-month post-operative follow-up, all of which indicates that the Contour Neurovascular System is well positioned to meet the requisite endpoints of the US study.
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