Emphasys Medical Announces PMA Submission for Bronchial Val... (

Emphasys Medical Announces PMA Submission for Bronchial Valve Therapy

Date:10/1/2007

- Data from Positive VENT Trial Presented at ERS 17th Annual Congress -

REDWOOD CITY, Calif., Oct. 1 /PRNewswire/ -- Emphasys Medical Inc. today announced the submission of a pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) requesting regulatory approval to market the Emphasys endobronchial valve, the Zephyr(R) EBV, in the United States. The Zephyr EBV is a minimally invasive and potentially reversible treatment option intended to help patients with emphysema breathe easier.

The PMA submission was based on data from the company's pivotal trial, the Endobronchial Valve for Emphysema PalliatioN Trial (VENT). VENT was a randomized, multi-center trial enrolling 321 patients with severe heterogeneous emphysema. This trial was designed based on input from a panel of expert clinicians convened by the FDA in February 2003 to help establish the appropriate clinical endpoints for medical device treatments of emphysema. The VENT study's primary efficacy endpoints were improvement in lung function as measured by forced expiratory volume in one second (change in FEV1) and exercise tolerance as measured by a six minute walk test (6MWT) both at six months. The primary safety endpoint was a composite of major complications at six months.

Data from VENT was recently presented at the European Respiratory Society (ERS) 17th Annual Congress. VENT met both its primary efficacy endpoints showing statistically significant improvements in lung function (p=0.0047) and exercise tolerance (p=0.0073). VENT also showed the Zephyr EBV to have a favorable safety profile in terms of major complications between the treatment and control groups. At the six-month follow-up, protocol-defined major complications occurred in 5.9% of treated patients compared to 1.0% of control patients. The difference did not reach statistical significance. Investigators also reported on select patient subsets. In patients defined as having physiologically isol
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