ETView Medical, Ltd. Announced Filing of a 510(k) Pre‐Marketing Notification Application with the US Food and Drug Administration for the Viva™ EB Line of Innovative Endobronchial Blockers
The Viva™ EB product family provides endobronchial blockade of the right or left lung for thoracic surgical procedures requiring lung isolation.
February 6, 2012, Tel Aviv, Israel‐ETView (TASE: ETVW) today announced that the company has successfully completed filing of a Pre‐Marketing Notification Application (510(k)) 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 Viva™ EB during 2012. Additional pre‐market regulatory filings 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 patented 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.1 It is estimated that over 1.9 million lung‐isolation procedures are conducted worldwide annually,2 accounting for over $250MM in single‐use medical disposables.3
“We are excited to have reached this milestone”, stated Bill Edelman, CEO. He continued, “Viva™ EB 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 the combined VivaSight™‐SL/Viva™ EB products when Viva™ EB is cleared for commercial distribution.”
During February 2012, ETView announced distribution agreements with NeuroMed Ltd. (NeuroMed), a surgical products sales and distribution company based in St. Petersburg, Russia, and State of the Art (SOTA) Medical Products, Inc., a specialty surgical products sales and distribution company, based in Cedar Grove, New Jersey.
On December 12, 2011, ETView announced that the company filed a Pre‐Marketing Notification Application (510(k)) with the FDA for the VivaSight™‐DL Airway Management System. VivaSight™‐DL4 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.
About ETView, Medical, Ltd.
ETView Medical Ltd. (TASE: ETVW) 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 bronchoscope5 imaging during these procedures). ETView's patented VivaSight™‐SL, a single‐use, disposable medical device consisting of a singlelumen 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.6 Visit www.etview.com for additional information.
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 Principles and Practices of Anesthesia for Thoracic Surgery P. Singer (ed.) 2011
2 National Health Statistics Reports Number 29, October 26, 2010
3 Company estimates on file
4 Patent Pending
5 Minerva Anestesiol 2009;75(Suppl 1):1-4.
6 Anesthesiology 2006;105:471–7.