Emphasys Medical Announces Positive Data From Pivotal Trial for Patients With Emphysema
VENT was a randomized, multi-center trial evaluating the efficacy andsafety of the Zephyr EBV in 321 patients with severe heterogeneous emphysema.The trial was designed based on input from a panel of expert cliniciansconvened by the U.S. Food and Drug Administration (FDA) in February 2003 tohelp establish the appropriate clinical endpoints for medical devicetreatments of emphysema. The VENT study's primary efficacy endpoints wereimprovement in lung function as measured by forced expiratory volume in onesecond (change in FEV1) and exercise tolerance as measured by a six minutewalk test (6MWT) both at six months. The primary safety endpoint was acomposite of major complications at six months.
VENT met both of its primary efficacy endpoints showing statisticallysignificant improvements in lung function (p=0.0047) and exercise tolerance(p=0.0073). VENT also showed the Zephyr EBV to have a favorable safety profilein terms of major complications between the treatment and control groups. Atthe six-month follow-up, protocol-defined major complications occurred in 5.9%of treated patients compared to 1.0% of control patients. The difference didnot reach statistical significance. Investigators also reported on selectpatient subsets. In patients defined as having physiologically isolated targetlung zones and correct Zephyr EBV placement, FEV1 was increased by 21%(p<0.0001).
"The positive results of VENT demonstrate that this minimally invasivetherapy may improve the quality of life of patients with emphysema and may setthe standard for future research in the field of endobronchial valve therapy,"said Dr. Strange.
Emphasys recently submitted a pre-market approval (PMA) application to theFDA 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 limitedbasis in Europe and in certain Asia-Pacific regions including Australia, HongKong and Singapore. The Zephyr EBV system is limited to investigational use inthe United States.
The Zephyr EBV is a small one-way silicone valve that is inserted intoairways to prevent air from entering the diseased portion of the lung duringinhalation and designed to allow air and fluids to escape during exhalation.The Zephyr EBV is intended to mitigate the effects of emphysema by isolatingthe targeted diseased portion of the lung, causing a reduction in volume ofthe diseased region and allowing the healthier portions of the lung tofunction more normally. The Zephyr EBV has also been used for the treatmentof lung air leaks in limited circumstances under a compassionate use protocolapproved by the FDA on a case-by-case basis. Procedures using the Zephyr EBVare potentially reversible, if necessary, and the valves can be removed withstandard bronchoscopic tools.
About Emphasys Medical
Based in Redwood City, California, Emphasys Medical is a medicaltechnology company focused on developing and commercializing therapeuticdevices for the treatment of patients with emphysema and other debilit
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