ETView Medical, Ltd. Announces Filing of a 510(k) Pre‐marketing Notification Application with the US FDA for the VivaSight™‐DL line of Innovative Airway Devices.
The VivaSight™‐DL product family provides continuous airway visualization during thoracic surgical procedures requiring lung isolation.
December 12, 2011, Tel Aviv, Israel‐‐ETView (TASE: ETVW) today announced that the company has successfully completed filing of a 510(k) Pre‐Marketing Notification Application with the US Food and Drug Administration (FDA). The Company expects feedback from the FDA during the next quarter and anticipates entering the US market with the VivaSight™‐DL Airway Management System during 2012. Additional pre‐market regulatory filings in Europe and Asia are anticipated during 2012.
About the VivaSight™‐DL Airway Management System
VivaSight™‐DL1 is a proprietary, single‐use, disposable medical device, consisting of a duallumen 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 patent 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 $250mm in single‐use medical disposables.5 ETView has pioneered development of the VivaSight™ platform (previously known as TVT™), 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).
“We are excited to have reached this milestone,” stated Bill Edelman, CEO. He continued, “VivaSight™‐DL will be available to the US thoracic surgical community following FDA concurrence with our 510(k) pre‐market application. We anticipate significant clinical interest for this innovative technology in the markets where VivaSight™‐DL will be cleared for commercial distribution.”
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™‐SL, a single‐use, disposable medical device consisting of a single‐lumen ventilation tube with an integrated, continuous, high‐resolution video imaging system, is currently sold in Europe, Israel, and the US to overcome current limitations and associated adverse surgical events during lung isolation surgeries.7 Visit www.etview.com for additional information.
The Company estimations in this press release, including those estimations regarding the Company's predicted scope of business, constitute forward‐looking statements, as such term is defined under the Israeli Securities Law (5728‐1968), and there is no certainty that such estimations shall materialize. The Company's estimations are based on business assumptions, prior experience, and professional data. Due to various factors, foreseen and unforeseen, including, but not limited to, changes in market trends, competition, global or local economic conditions, and amendments of regulation, such estimations may not materialize in whole or in part, or materialize in a substantially different manner than anticipated by the Company.
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 Anestesiol. 2009;75(Suppl 1):1‐4.
7 Anesthesiology. 2006;105:471‐477.