Emphasys Medical Announces Positive Data From Pivotal Trial for Patients With Emphysema
Published: Oct 22, 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 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 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 of patients with emphysema and other debilitating breathing disorders.
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