The Food and Drug Administration (FDA) has given 510(k) clearance to ActiViews to market its CT-Guide needle guidance system for lung interventions. This guidance system is an accessory for CT scanners and is designed to assist physicians during CT-guided interventional procedures.
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.
The CT-Guide needle guidance system enables physicians to locate interventional instruments in relation to pre-acquired CT images. 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.
“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 Narinder Paul, Division Chief Cardiothoracic Imaging at University of Toronto and principal investigator in the confirmatory FDA study.
Kieran Murphy, professor and vice-chair of Medical Imaging at University of Toronto, commented, “Over the past decade the amount of patients benefiting from minimal invasive surgeries has exploded due to rapid developments in medical imaging and medical devices. ActiViews’ CT-Guide navigation is another important step forward that may allow lung interventions like biopsies, drainages, or ablations to be performed faster, safer, and more predictable.”
“We look forward to making CT-Guide navigation available to US interventional radiologists at selected hospitals this fall under a controlled-market release, and to make the system broadly available in 2012,” commented Christopher von Jako, president of ActiViews.