EndoVantage Secures 510(k) Clearance from FDA for SurgicalPreview™

SCOTTSDALE, AZ – November 8, 2017 – EndoVantage, LLC, a pioneer in cloud-based medical simulation technology, today announced its receipt of 510(k) clearance from the U.S. Food and Drug Administration for SurgicalPreview™, its preoperative planning system for the endovascular treatment of cerebral aneurysms.

A cerebral aneurysm is a weak spot in a blood vessel in the brain that balloons out and fills with blood. Aneurysms may burst and bleed into the brain, causing serious complications, including hemorrhagic stroke, permanent nerve damage, or death. Treatment includes the use of a device to divert blood flow away from the aneurysm. It can be challenging to select the precise size of device for a patient’s artery and to place it correctly. SurgicalPreview™ enables the clinician to plan the procedure before surgery and visualize how the device fits.

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