ETView Medical, Ltd. Announced CE Clearance 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.
June 25 2012, Tel Aviv, Israel‐ ETView (TASE: ETVW) today announced that the company has received pre-market clearance for the ViVaSight™-DL product family following review of a Technical File submission by Medical Device Certification GmbH (“MDC”). The 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 VivaSight™‐DL line of innovative airway devices in countries requiring CE registration of medical devices. In May, 2012, VivaSight-DL 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 VivaSight™‐DL Airway Management System
VivaSight™‐DL 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. 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. It is estimated that over 1.9 million lung isolation procedures are conducted worldwide annually, accounting for over $250mm in single‐use medical disposables. 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 bronchoscope imaging during these procedures).
“We are excited to have reached this milestone”, stated Bill Edelman, CEO. He continued, “VivaSight™‐DL 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,” formerly EC mark ) 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.
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.
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.