TEL AVIV, Israel--(BUSINESS WIRE)--ETView (TASE: ETVW) today announced that the company has received European pre-market clearance for the Viva™-EB product family following review of a Technical File submission by Medical Device Certification GmbH (“MDC”). The European pre-market clearance completes the Conformité Européenne, or "European Conformity” (“CE”) registration process. Following award of CE registration, the Company expects to immediately begin distribution of the Viva™-EB line of innovative airway devices in countries requiring CE registration of medical devices. In June, 2012, Viva™-EB received US FDA clearance of a 510(k) Pre-Marketing Notification. 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 world-wide annually2, accounting for over $250MM in single-use medical disposables3.
“We are excited to have reached this milestone,” stated Bill Edelman, CEO. He continued, “Viva™-EB will be immediately available to the European thoracic surgical community following MDC concurrence with our CE registration application. We anticipate significant clinical interest for VivaSight™‐DL when it is cleared for commercial distribution.”
On June 12, 2012, ETView announced US FDA Clearance of a 510(k) Pre-Marketing Notification Application for the Viva™-EB Line of Innovative Endobronchial Blockers.
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 the CE Mark
The CE mark (Conformité Européenne, meaning "European Conformity,”4 formerly EC mark5) according to the European Medical Directive (MDD), is a mandatory conformity mark for medical devices placed on the market in the European Economic Area (EEA). With the CE marking on a medical device, the manufacturer ensures that the product conforms to the essential requirements of the applicable EC medical device directives.6
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
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 http://ec.europa.eu/enterprise/faq/index_en.htm#09012624859cd715
5
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0068:en:HTML
6
http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/faq/index_en.htm
7
Anesthesiology. 2006;105:471-477.