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April 21, 2021
Cerus Receives IDE for Trial of Contour Neurovascular System to Support FDA Approval
April 21, 2021—Cerus Endovascular Ltd. announced that the FDA has approved its investigational device exemption (IDE) application to conduct a United States trial for the Contour neurovascular system, which is indicated for the treatment of intracranial aneurysms. In February, the company announced the FDA granted Breakthrough Device designation for the device.
According to the company, the study is designed to develop a robust data set to support the safety and efficacy of the Contour neurovascular system for the endovascular embolization of wide-necked, bifurcated, saccular intracranial aneurysms. Study results will be submitted 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 3 months,” commented Cerus Endovascular’s President Stephen Griffin, PhD, in the company’s press release. “The IDE study protocol closely aligns with protocols of other intrasaccular 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.”
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