ActiViews, Inc. Announces FDA 510(k) Clearance of CT-Guide™ Needle Guidance System for Lung Interventions

WAKEFIELD, Mass.--(BUSINESS WIRE)--ActiViews, Inc., an early stage company pioneering the development of cost-effective interventional medical navigation instrumentation, 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 lung interventions.

“We look forward to making CT-Guide™ navigation available to U.S. interventional radiologists at selected hospitals this fall under a controlled-market release, and to make the system broadly available in 2012.”

CT-Guide™ navigation is an accessory for CT scanners and is designed to assist physicians during CT-guided interventional procedures. This first generation system has been cleared for interventional applications in the lungs. 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 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.

“Today’s announcement represents the successful culmination of a two-year effort by the ActiViews staff, our advisors, and interventional radiologists to bring CT-Guide™ navigation to the U.S. market,” commented Christopher von Jako, President of ActiViews, Inc. “We look forward to making CT-Guide™ navigation available to U.S. interventional radiologists at selected hospitals this fall under a controlled-market release, and to make the system broadly available in 2012.”

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.

"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," said Dr. Kieran Murphy, Professor and Vice Chair of Medical Imaging at University of Toronto.

About Lung Cancer:

The most recent estimates indicate that over 220,000 new cases of lung cancer will be diagnosed each year in the United States. According to the American Cancer Society, lung cancer is by far the leading cause of cancer death among both men and women. In fact, more people die of lung cancer than of colon, breast, and prostate cancers combined. More information on lung cancer can be found at www.cancer.org.

About ActiViews:

ActiViews, Inc. is a privately held company that develops, manufactures, and markets navigation solutions to assist physicians in minimally invasive procedures. The company mission is to provide clinicians with simple, innovative solutions to enhance their experience in performing image-guided interventional procedures. The U.S. Patent and Trademark Office have approved the company’s core technology patent with several other patents pending. ActiViews, Inc. is located in the metro-Boston area with Research and Development facilities in Haifa, Israel. For further information visit the website at www.activiews.com. ActiViews, Navigate with Confidence™.

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