FDA approves cloud-based aneurysm planning technology
The Food and Drug Administration has approved a cloud-based medical simulation technology that enables pre-operative planning for treating cerebral aneurysms by endovascular means.
EndoVantage, based in Scottsdale, Ariz., has received 510(k) clearance from the FDA for its SurgicalPreview application, which enables clinicians to plan procedures to resolve aneurysms in the brain.
Clinicians can use any computer with Internet to access SurgicalPreview and upload a patient’s CT imaging data. The system then converts that two-dimensional data to a functional three-dimensional model, enabling the clinician to manipulate the model as well as take anatomical measurements.
Such pre-surgery planning is particularly important in procedures that involve work within blood vessels in the brain.
A cerebral aneurysm is a weak spot in a blood vessel in the brain that 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, but it is difficult to select the precise size of device for a patient’s artery and to place it correctly.
The EndoVantage application enables the clinician to plan the procedure before surgery and visualize how the device will fit. It uses DICOM-based images as well as existing 3-D images for the modeling.
The clinician also may use the application to request computational models of multiple treatment scenarios for a patient, each representing a different treatment device or deployment strategy. The application includes a library of 3D models of neurological treatment devices approved by the FDA from which the clinician can select. The clinician can then view side-by-side static models and video models of the catheter delivery, landing and deployment.
More information can be found here.