VBT’s Medical Device Sponsor Announces FDA 510(k) Clearance of Proprietary Needle Guidance System for Lung Interventions
July 13, 2011, Montreal, Canada – One of Vantage BioTrials’ early stage medical device sponsors (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, a Proprietary Needle Guidance System, for lung interventions. Vantage BioTrials’ Project Management and Clinical Monitoring teams were instrumental in setting up and managing the clinical trial for this product in Canada over the past 12 months, and obtaining very successful results.
“Today’s announcement represents the successful culmination of a two-year effort by our staff, Vantage BioTrials, our advisors, and interventional radiologists to bring our navigation system to the U.S. market,” commented the President of the medical device company. “We look forward to making our navigation system 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, the company concluded a confirmatory safety and effectiveness clinical trial in February at four hospitals in Canada, which was managed by Vantage BioTrials clinical staff. The study yielded 100% success in the primary end point of targeting accuracy with the navigation system.
“With over 100 cases performed at our institution, we demonstrated that the navigation system 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. This new navigation system 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.