The US Food and Drug Administration (FDA) has cleared 510(k) pre-marketing notification application (PMA) of ETView Medical's Viva EB Endobronchial blocker.
Viva EB comprises 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.
Viva EB, when used in combination with a fiberoptic bronchoscope, is employed with an endotracheal tube to block the right or left lung for thoracic surgical procedures requiring lung isolation.
The blocker is compatible with the company’s patented VivaSight-SL, a single-use disposable single lumen ventilation tube with an integrated continuous video imaging system for use in lung isolation procedures.
ETView Medical CEO Bill Edelman said Viva EB is now available to the US thoracic surgical community following FDA clearance of its 510(k) pre-market application.
"We look forward to additional regulatory clearances worldwide which will expand the market for our VivaSight portfolio," Edelman added.
The company said additional pre-market regulatory clearances in Europe and Asia are anticipated during 2012.