Emphasys Medical Announces Positive Data From Pivotal Trial for Patients With... (

Emphasys Medical Announces Positive Data From Pivotal Trial for Patients With Emphysema

Date:10/22/2007

- Results Presented at CHEST 2007 -

CHICAGO, and REDWOOD CITY, Calif., Oct. 22 /PRNewswire/ -- Emphasys Medical, Inc. today presented positive results from the company's pivotal Endobronchial Valve for Emphysema PalliatioN Trial (VENT), showing that the company's Zephyr(R) Endobronchial Valve (EBV) improved lung function and exercise tolerance in patients with emphysema. These data were presented at the CHEST 2007 meeting in Chicago, Illinois in a symposium titled, "Results of VENT: Endobronchial Valves for Emphysema Palliation Trial," which was co-chaired by Dr. Charlie Strange from the Medical University of South Carolina in Charleston, and Dr. Marc Noppen from the University Hospital AZ-VUB in Brussels Belgium. The Zephyr EBV is a minimally invasive and potentially reversible treatment option intended to help patients with emphysema breathe easier.

VENT was a randomized, multi-center trial evaluating the efficacy and safety of the Zephyr EBV in 321 patients with severe heterogeneous emphysema. The trial was designed based on input from a panel of expert clinicians convened by the U.S. Food and Drug Administration (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.

VENT met both of 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 t
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