Pulmonx SARL today announced that its European notified body has granted CE approval for expanded labeling of its Zephyr® endobronchial valve (EBV). The approval was based upon an independent review of clinical data from numerous studies including the recently completed Chartis multi-center study and the European VENT study (a randomized multi-center European trial of Zephyr EBV therapy). The Chartis Multi-Center Study data was presented at the European Respiratory Society's 2011 Congress in September and the data from the European VENT study was accepted in December 2011 for publication in the European Respiratory Journal.
“This reinforces my belief that Chartis and EBV treatment should become a standard-of-care in the management of emphysema.”
These new data sets confirm that Zephyr EBV treatment is a safe and efficacious approach to managing the crippling hyperinflation that occurs in emphysema patients regardless of the degree of disease heterogeneity that is observed on a patient's CT examination. Earlier studies had established the safety and efficacy of Zephyr EBV therapy in patients with a relatively high disease heterogeneity score on CT examination. The new data and the newly approved labeling clear the way for physicians to use Zephyr EBV therapy to treat a much broader range of the population of patients afflicted with emphysema.
"The most recent data clearly confirms that EBV therapy should not be restricted to only those patients whose emphysema is scored as highly heterogeneous on CT examination and that it can be safely used to treat hyperinflation in a broad range of emphysema patients," said Professor Felix Herth, MD, PhD., FCCP, Chairman and Head of Pneumology and Respiratory Care at Thoraxklinik, University of Heidelberg, Germany. "This reinforces my belief that Chartis and EBV treatment should become a standard-of-care in the management of emphysema."
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