TEL AVIV, Israel--(BUSINESS WIRE)--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 Viva™ EB immediately. Additional pre-market regulatory clearances in Europe and Asia are anticipated during 2012.
About the Viva™ EB Endobronchial Blocker
Viva™ EB consists of a sterile, single-use, steerable, balloon tipped catheter which is guided under video imaging to a selected bronchial segment to affect balloon blockage of the distal airway. Air is subsequently evacuated through a dedicated channel, deflating the selected lung and establishing lung isolation. Viva™ EB is employed with an endotracheal tube when used in combination with a fiberoptic bronchoscope to blockade the right or left lung for thoracic surgical procedures requiring lung isolation. Viva™ EB is compatible with ETView's patented1 VivaSight™-SL, a single-use disposable single lumen ventilation tube with an integrated continuous high resolution video imaging system for use in lung isolation procedures. VivaSight™-SL has been cleared for commercial distribution by the FDA. Lung isolation is employed to provide one-lung ventilation in patients undergoing thoracic, cardiac, vascular or esophageal surgeries.2 It is estimated that over 1.9 million lung isolation procedures are conducted world-wide annually3, accounting for over $250MM in single-use medical disposables4.
"We are excited to have reached this milestone," stated Bill Edelman, CEO. He continued, "Viva™ EB 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 Viva™ EB is cleared for commercial distribution. With our complete line of VivaSight™ products 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 worldwide which will expand the market for our VivaSight™ portfolio."
On June 4, 2012, ETView announced the appointment of David Amar, MD, to its Scientific Advisory Board.
On May 23, 2012, ETView announced US FDA clearance of a 510(k) Pre-Marketing Notification Application for the VivaSight™-DL 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. 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.5
Forward Looking Statement
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 Patents issued and pending
2 Principles and
Practices of Anesthesia for Thoracic Surgery P. Singer (ed.) 2011
3
National Health Statistics Reports Number 29, October 26, 2010
4
Company estimates on file
5 Anesthesiology,
2006;105:471-477