ETView Medical has won European pre-market clearance for the Viva-EB product family, designed to provide endobronchial blockade of the right or left lung for thoracic surgical procedures requiring lung isolation.
The clearance, which completes the European Conformity (CE) registration process, follows the review of a technical file submission by Medical Device Certification (MDC).
ETView CEO, Bill Edelman, said Viva-EB will be immediately available to the European thoracic surgical community following MDC concurrence with the CE registration application.
"We anticipate significant clinical interest for VivaSight-DL when it is cleared for commercial distribution," Edelman added.
The company expects to commence distribution of the Viva-EB line of airway devices in countries requiring CE registration of medical devices immediately.
Viva-EB consists of a sterile, single-use, steerable, balloon-tipped catheter guided under video imaging to a selected bronchial segment to affect balloon blockage of the distal airway.
Air is then evacuated through a channel, deflating the selected lung and establishing lung isolation, according to the company.
Viva-EB, which is compatible with ETView’s patented VivaSight-SL, is employed with an endotracheal tube when used in combination with a fibre-optic bronchoscope to blockade the right or left lung.
VivaSight-SL is a single-use, disposable, single-lumen ventilation tube with an integrated, continuous high-resolution video imaging system for use in lung isolation procedures.
The USFDA granted 510(k) clearance for Viva-EB in June 2012, while additional pre-market regulatory filings in Europe and Asia are anticipated later on in the year.