ETView Medical has announced it has received FDA 510(k) clearance for its Viva EB line of endobronchial blockers, according to a news release (pdf).
The Viva EB endobronchial blocker is 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. It is used during thoracic surgical procedures requiring lung isolation.
"We are excited to have reached this milestone," said Bill Edelman, CEO of ETView Medical, in the release. "Viva EB is now available to the U.S. thoracic surgical community following FDA clearance of our 510(k) pre-market application. We anticipate significant clinical interest for this innovative technology in the markets where Viva EB is cleared for commercial distribution."
ETView expects to enter the U.S. market with the Viva EB immediately. Additional pre-market regulatory clearances in Europe and Asia are anticipated during 2012.
ETView Medical is headquartered in Tel Aviv, Israel.
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