The US Food and Drug Administration (FDA) has granted 510(k) approval to ActiViews' CT-Guide needle guidance system for liver interventions.
The FDA approval was based on a positive clinical trial conducted in December at two hospitals affiliated with McGill University Health Center in Montreal, Quebec, Canada.
The clinical study met primary end point of targeting accuracy with CT-Guide navigation used in biopsy and radiofrequency and microwave ablation procedures, and there were no device related adverse events.
CT-Guide system features a single-use miniature video camera, a patented sterile registration sticker, and a proprietary 3D software that is viewed on a HD flat panel monitor mounted on a mobile workstation.
CT-Guide navigation is designed to facilitate physicians during CT-guided interventional diagnostic and therapeutic procedures such as percutaneous biopsies, ablations and marker placements in the lung and liver.
ActiViews said CT-Guide navigation allows physicians to determine the location of the navigated instrument in relation to the 3D space of the CT images and the desired target, continuously displaying the location of the instrument and its planned path on the CT image of the patient’s anatomy.