FDA accepts ET View's balloon catheter application

ET View Medical Ltd. (TASE: ETVW) today announced that the US Food and Drug Administration (FDA) has accepted the company's application for its Viva-EB disposable balloon bronchial blocker. The company expects to the FDA's response during the second quarter.

The Viva-EB balloon catheter is visually inserted into the bronchial tubes to block one lung. After insertion, air is pumped from the lung by a proprietary tube. The device is adapted for use with the company VivaSight SL (single lumen) disposable high-resolution camera catheter, which provides continuous visualization for intubation for cardio-pulmonary, vascular, or bronchial surgical procedures.

ET View has also filed marketing applications for the Viva-EB in Europe and in Asian countries.

ET View cites a report, which says that 1.9 million lung blocking procedures are carried out annually in the US.

ET View CEO Bill Edelman said, "After the FDA approves the Viva-EB device, it will be available for use by US chest surgeons. We expect strong clinical interest in the combined use of the product with the VivaSight SL device following approval of the Viva-EB."

ET View's share price rose 3.2% by midday today to NIS 1.46, giving a market cap of NIS 56 million.

Published by Globes [online], Israel business news - www.globes-online.com - on February 5, 2012