Olympus Spiration Valve System is FDA approved for the endobronchial treatment

Olympus has received FDA approval for its Spiration Valve System (SVS) for the treatment of severe emphysema, a progressive form of chronic obstructive pulmonary disease (COPD). In addition to being designated a breakthrough medical device, the SVS was granted priority review status by the FDA because it is intended to treat a life-threatening or irreversibly debilitating disease or condition and offers significant, clinically meaningful advantages over existing legally marketed alternatives. FDA approval of the SVS is based on results of the EMPROVE clinical trial demonstrating that patients treated with the SVS benefited from statistically significant and clinically meaningful improvements in lung function and quality of life compared to standard of care medical management. Further, the results showed that the SVS offers a favorable risk benefit profile, with a short procedure time, which may reduce the risk of adverse events. Serious adverse events observed in the study include COPD exacerbations, air leak (pneumothorax), pneumonia, and death.