Massachusetts-based ActiViews received FDA clearance to bring to market its CT-Guide Needle Guidance System, indicated as a tool to identify the real time location of instruments within the patient during CT-guided interventional lung procedures. Using pre-acquired CT images, a camera, and markers, the system displays the location of the needles on a nearby workstation.
CT-Guide™ navigation features a single-use miniature video camera that is easily affixed onto standard interventional instruments, a sterile registration patch, and proprietary 3D software that is viewed on a HD flat panel monitor mounted on a mobile workstation. The workstation is placed adjacent to the CT scanner table where updated CT images can be taken whenever required. The system helps physicians determine the spatial 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 lung interventions, ActiViews concluded a confirmatory safety and effectiveness clinical trial in February at four hospitals in Canada. The clinical study yielded 100% success in the primary end point of targeting accuracy with CT-Guide™ navigation.
“With over 100 cases performed at our institution, we demonstrated that CT-Guide™ navigation could be used in tandem with a conventional coaxial needle biopsy system. We also experienced fewer biopsy needle redirects and check CT scans during the procedure, reflecting increased confidence by the interventional radiologists,” said Dr. Narinder Paul, Division Chief Cardiothoracic Imaging at University of Toronto and Principle Investigator in the confirmatory FDA study.
Product page: CT-Guide…