Spiration valve to treat emphysema gets US nodFebruary 4, 2019
The US FDA approved Spiration Valve System (SVS) for the treatment of severe emphysema, a progressive form of Chronic Obstructive Pulmonary Disease (COPD), Olympus said.
Placed in targeted airways of the lung during a short bronchoscopic procedure, the Spiration Valve is an umbrella-shaped device that improves breathing by blocking airflow to the diseased portion of the lung. SVS therapy leads to volume reduction in the treated part of the lung, allowing the healthier tissue in the remaining portion of the lung to function better.
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 favourable risk-benefit profile, with a short procedure time, which may reduce the risk of adverse events.
Prominent guidelines now recommend minimally invasive bronchoscopic lung volume reduction using endobronchial valves as an alternative treatment option for severe emphysema to more invasive options, such as open surgery.
The SVS is now approved for use in emphysema in the US, EU, Australia and New Zealand.