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# FDA Approves Olympus Device for Emphysema
- URL: https://www.fdaweb.com/fda-approves-olympus-device-for-emphysema/
- Published: 2018-12-05T12:00:00.000Z
- Updated: 2026-09-15T00:48:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142968

FDA has approved Olympus’ Spiration Valve System (SVS) for treating severe emphysema, a progressive form of chronic obstructive pulmonary disease (COPD). Approval was based on data from 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,” the company says. Additionally, it says that data showed the device offers a favorable risk benefit profile related to its short procedure time, which may reduce adverse event risks. Serious adverse events observed in the study include COPD exacerbations, air leak (pneumothorax), pneumonia and death.

The SVS is placed in targeted airways of the lung during a short bronchoscopic procedure. Its umbrella shape is designed to improve breathing by blocking airflow to the diseased portion of the lung, Olympus says. “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,” it adds.