ETView Medical has obtained European pre-market clearance for Viva-EB line of endobronchial blockers.
The Viva-EB product family are designed to provide endobronchial blockade of the right or left lung for thoracic surgical procedures requiring lung isolation.
ETView Medical CEO Bill Edelman said Viva-EB will be immediately available to the European thoracic surgical community following Medical Device Certification concurrence with the CE registration application.
"We anticipate significant clinical interest for VivaSight(TM)-DL when it is cleared for commercial distribution," Edelman added.
Viva-EB, which is compatible with the company’s patented VivaSight-SL, comprises 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.
Viva-EB is employed with an endotracheal tube when used in combination with a fibre-optic bronchoscope to blockade the right or left lung, according to the company.
The FDA granted 510(k) clearance for Viva-EB in June 2012, while additional pre-market regulatory filings in Europe and Asia are anticipated during 2012.