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Share this article Share this article FREMONT, Calif. and OXFORD, United Kingdom, April 21, 2021 /PRNewswire/ Cerus Endovascular Ltd., a privately held, commercial-stage medical device company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to conduct a U.S. trial for the Contour Neurovascular System™, indicated for the treatment of intracranial aneurysms. The IDE approval follows the receipt of Breakthrough Device Designation from the FDA in February 2021. We are eager to move ahead with this important trial and anticipate patient enrollment beginning within the next three months, stated Dr. Stephen Griffin, President of Cerus Endovascular. 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 Syste ....
Cerus Endovascular Receives FDA Breakthrough Device Designation for its Contour Neurovascular System™ News provided by Share this article Share this article FREMONT, Calif. and OXFORD, United Kingdom, Feb. 11, 2021 /PRNewswire/ Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Contour Neurovascular System™. Breakthrough Device Designation is granted to medical devices and device-led combination products that provide the potential for a more effective treatment option for life-threatening or irreversibly debilitating diseases. The designation expedites the traditional development, assessment and review process, and enables medical professionals to get access to new developments quickly. ....