ETView Medical, Ltd. Announces US FDA Clearance of a 510(k) Pre-marketing Notification Application Expanding the VivaSight-DL line of Innovative Airway Devices
ETView has announced that the company has 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 current distributes the VivaSight™- DL Airway Management System in the US. Additional pre-market regulatory clearances in Europe and Asia are anticipated during 2013.
About the VivaSight™- DL Airway Management System 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 bronchoscope 6 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," stated Bill Edelman, CEO. He continued, "We anticipate significant clinical interest for this innovative technology in the markets VivaSight™- DL is cleared for commercial distribution. With both VivaSight™-S L 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."
On March 18, 2013, ETView Medical, Ltd., announced State Food and Drug Administration (SFDA, China) clearance of a Pre-marketing Notification Application for the VivaSight™-SL Line of Innovative Airway Devices
About ETView, Medical, Ltd.
ETView Medical Ltd. (TASE: ETVW) has successfully combined airway management with continuous direct airway visualization for medical professionals. ETView's patented VivaSight™ airway management portfolio consists of single-use disposable medical devices, representing either single or double lumen ventilation tubes with an integrated continuous high resolution airway imaging system.
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