Expanding VivaSight-DL Line

ETView received clearance of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration (FDA) expanding the available sizes of the VivaSight-DL Airway Management System. The Company currently distributes the VivaSight-DL Airway Management System in the US. Additional pre-market regulatory clearances in Europe and Asia are anticipated during 2013.

VivaSight-DL¹ is a proprietary, single-use disposable medical device, consisting of a dual lumen airway ventilation tube with an integrated continuous high-resolution video airway imaging system permitting airway control and lung isolation during certain surgical procedures. Lung isolation is employed to provide one-lung ventilation in patients undergoing thoracic, cardiac, vascular, or esophageal surgeries.² During lung isolation, temporary visualization of the patient airway is achieved with a fiberoptic bronchoscope while the patient is ventilated and the target lung isolated. Intra-operative surgical maneuvers often require repeated imaging and partial blocking of the airway to maintain lung isolation.³ It is estimated that over 1.9 million lung isolation procedures are conducted worldwide annually,⁴ accounting for over $250M in single-use medical disposables.⁵ ETView has pioneered development of the VivaSight platform, combining an airway ventilation tube with integrated continuous high resolution airway imaging for patient airway control and lung isolation capability (eliminating the need for fiberoptic bronchoscope⁶ imaging during these procedures).

"With this new 510(k) clearance, we are able to expand the range of VivaSight-DL sizes available to the clinical community," statess Bill Edelman, CEO. "We anticipate significant clinical interest for this innovative technology in the markets VivaSight-DL is cleared for commercial distribution. With both VivaSight-SL and VivaSight-DL available in the US, ETView offers a complete airway management solution for 100% of lung-isolation surgeries. We look forward to additional regulatory clearances world-wide which will expand the market for our VivaSight portfolio."

1 Patent Pending
2 Principles and Practices of Anesthesia for Thoracic Surgery. P. Singer (ed.) 2011
3 Anesthesia & Analgesia. 2009;108:1097–101
4 National Health Statistics Reports Number 29, October 26, 2010
5 Company estimates on file
6 Minerva Anesthesiology. 2009;75(Supplement 1):1-4