Emphasys Medical Granted Expedited Review From FDA for Zephyr(R) Endobronc...( REDWOOD CITY Calif. Oct. 30 /- Em...),Health

REDWOOD CITY, Calif., Oct. 30 /PRNewswire/ -- Emphasys Medical, Inc. today announced that its pre-market approval (PMA) application for the Zephyr(R) Endobronchial Valve (EBV) has been accepted as suitable for filing by the U.S. Food and Drug Administration (FDA) and has been granted expedited review. The Zephyr EBV is a minimally invasive treatment option intended to help patients with emphysema breathe more easily. The FDA granted expedited review based on the potential of endobronchial valve treatment to offer a viable alternative to surgery in some patients for the treatment of emphysema, and the lack of a therapeutic device to address this potentially life-threatening or irreversibly debilitating disease.

Submitted to the FDA in mid-September, the PMA application 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. The trial design was 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.

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 that the Zephyr EBV has a favorable safety profile in comparing 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 r
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