The US Food and Drug Administration (FDA) has given 510(k) clearance to ActiViews to market its CT-Guide Needle Guidance System for liver interventions.
CT-Guide navigation is designed to assist physicians during CT-guided interventional diagnostic and therapeutic procedures such as percutaneous biopsies, ablations, and marker placements in the lung and liver.
The system features a single-use miniature video camera that is easily affixed onto standard interventional instruments, a patented sterile registration sticker, and proprietary 3D software that is viewed on a HD flat panel monitor mounted on a mobile workstation. 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.
In support of its FDA medical device submission for liver interventions, ActiViews concluded a safety and effectiveness clinical trial in December at two hospitals affiliated with McGill University Health Center in Montreal, Canada. The clinical study yielded 100% success in the 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. These confirmed the safety and effectiveness of CT-Guide navigation for the liver indication.
“With our experience in over 150 procedures performed at our institution, we demonstrated that CT-Guide navigation is an ideal tool for various CT-guided interventional oncology applications. By being very easy-to-use and simple to learn, the ActiViews device enables even less experienced users to perform the procedures with the effectiveness and confidence of more advanced users, further enhancing the benefits of minimally invasive interventions to a wider range of patients.” said David Valenti, assistant professor and head of the Division of Interventional Radiology, McGill University Health Center, and principle investigator in the liver study.
“The simplicity and accuracy of the ActiViews system in guiding complex, deep and double angled needle approaches has been key in our adoption and repetitive usage in our minimally invasive interventional oncology procedures at McGill. Further, by eliminating most of the trial and error cycles involved in free hand guidance, the system has shown in some of our other preliminary comparative studies to shorten procedure time and reduce patient radiation exposure during the procedure,” said Tatiana Cabrera, assistant professor, Radiology, McGill University Health Center.