Emphasys Medical Submits PMA for Bronchial Valve Therapy
Emphasys Medical has submitted a premarket approval (PMA) application to the FDA requesting regulatory approval to market its Emphasys endobronchial valve, the Zephyr EBV, in the U.S.
The Zephyr EBV is a minimally invasive and potentially reversible treatment option intended to help patients with emphysema breathe easier, the company said.
The PMA submission was based on data from the company’s pivotal trial, the Endobronchial Valve for Emphysema Palliation Trial (VENT). A randomized, multicenter trial, VENT enrolled 321 patients with severe heterogeneous emphysema. The study’s primary efficacy endpoints were improvement in lung function as measured by forced expiratory volume in one second and exercise tolerance as measured by a six-minute walk test, both at six months, Emphasys said. 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 and exercise tolerance, the company said. VENT also showed the Zephyr EBV to have a favorable safety profile in terms of major complications between the treatment and control groups.
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