ActiViews CT-Guide Needle Guidance System Receives Additional FDA

ActiViews CT-Guide Needle Guidance System Receives Additional FDA Clearance for Liver Interventions

WAKEFIELD, Mass.–(BUSINESS WIRE)–ActiViews, Inc, a company pioneering the development of simple, accurate, and cost-effective surgical navigation solutions, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its flagship product, CT-Guide™ Needle Guidance System, for liver interventions.

“With today’s announcement, ActiViews further cements our commitment to become a leading provider of minimally invasive thoracic and abdominal surgical oncology solutions”

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 enables physicians to locate interventional instruments in relation to pre-acquired CT images, which is analogous to the way a GPS locates a car using stored roadmaps. CT-Guide™ navigation 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.

“With today’s announcement, ActiViews further cements our commitment to become a leading provider of minimally invasive thoracic and abdominal surgical oncology solutions,” commented Christopher von Jako, President of ActiViews, Inc. “With now our second successful clinical trial for the FDA with CT-Guide™ navigation, we are able to offer our customers an expanded indication from lung into liver and further clinical evidence of the efficacy of our unique and simple tool in these critical applications.”

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 Dr. 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 Dr. Tatiana Cabrera, Assistant Professor, Radiology, McGill University Health Center.

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.

h3h4hq3 ActiViews CT Guide Instrument Locator Gets U.S. Green Light

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.

Source : http://www.businesswire.com/news/home/20120423005074/en/ActiViews-Announces-FDA-510-Clearance-CT-Guide%E2%84%A2-Needle

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