ETView Medical, Ltd. announced US FDA Clearance of a 510(k) Pre-marketing Notification Application 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.
(May 23, 2012, Tel Aviv), ETView (TASE: ETVW) today announced that the company has received clearance of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration (FDA). The Company expects to enter the US market with the VivaSight™-DL Airway Management System immediately. Additional pre-market regulatory clearances 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 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).
"We are excited to have reached this milestone," stated Bill Edelman, CEO. He continued, "VivaSight(TM)-DL is now available to the US thoracic surgical community following FDA clearance of our 510(k) pre-market application. We anticipate significant clinical interest for this innovative technology in the markets where VivaSight(TM)-DL is cleared for commercial distribution. With both VivaSight(TM)-SL and VivaSight(TM)-DL available in the US, ETView can now offer 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(TM) portfolio."
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. VivaSight™-SL and VivaSight™-DL are currently sold in Europe, Israel, and the US to overcome current limitations and associated adverse surgical events during lung isolation surgeries.7
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):