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Emphasys Medical Announces Positive Data From Pivotal Trial for Patients With Emphysema
Date:10/22/2007

reated 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 isolated target lung zones and correct Zephyr EBV placement, FEV1 was increased by 21% (p<0.0001).

"The positive results of VENT demonstrate that this minimally invasive therapy may improve the quality of life of patients with emphysema and may set the standard for future research in the field of endobronchial valve therapy," said Dr. Strange.

Emphasys recently submitted a pre-market approval (PMA) application to the FDA requesting approval to market the Zephyr EBV in the United States.

About the Emphasys Zephyr(R) EBV

The company's Zephyr(R) EBV is CE marked and has been sold on a limited basis in Europe and in certain Asia-Pacific regions including Australia, Hong Kong and Singapore. The Zephyr EBV system is limited to investigational use in the United States.

The Zephyr EBV is a small one-way silicone valve that is inserted into airways to prevent air from entering the diseased portion of the lung during inhalation and designed to allow air and fluids to escape during exhalation. The Zephyr EBV is intended to mitigate the effects of emphysema by isolating the targeted diseased portion of the lung, causing a reduction in volume of the diseased region and allowing the healthier portions of the lung to function more normally. The Zephyr EBV has also been used for the treatment of lung air leaks in limited circumstances under a compassionate use protocol approved by the FDA on a case-by-case basis. Procedures using the Zephyr EBV are potentially reversible, if necessary, and the valves can be removed with standard bronchoscopic tools.

About Emphasys Medical

Based in Redwood City, California, Emphasys Medical is a medical technology company focused on developing and commercializing therapeutic devices for the treatment o
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SOURCE Emphasys Medical, Inc.
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