By Gerard J. Criner, MD, FACP, FACCP
The December 2018 announcement of FDA approval on the Olympus Spiration® Valve System (SVS) means patients now have a second option for minimally invasive endobronchial valve treatment for severe emphysema. The Spiration® Valve System was granted priority review status and approval under the FDA’s breakthrough medical devices designation following the EMPROVE trial—a multicenter, randomized and controlled study for which Temple was the lead enroller. An earlier Temple-led study, the LIBERATE trial, led to FDA approval of the Pulmonx Zephyr® endobronchial valve in June 2018.
Placed using a bronchoscope, one-way Spiration® Valves shrink emphysematous air pockets by allowing air to flow out of diseased lobes but not back in, providing more room for healthy sections of the lung to expand. The EMPROVE trial evaluated the use of the Spiration® Valve System in patients with severe airflow obstruction, dyspnea and hyperinflation due to emphysema.
The 12-month EMPROVE results—from 172 patients at 31 U.S. and Canadian centers—were announced at the European Respiratory Society International Congress (ERS) in September 2018. Results in the treatment group included a mean 52.8 percent volume reduction in targeted emphysematous lobes, leading to a 12 percent improvement in FEV1 at six months (an effect which persisted through 12 months) and a statistically significant 33 percent relative improvement in shortness of breath (measured by the mMRC score) compared to the control group.
The improvement in pulmonary function—especially the marked reduction of dyspnea, the most common symptom—is a crucial development for patients with severe emphysema and severe hyperinflation. We hope that with two endobronchial valve systems now available, more patients with this long-term, progressive disease will be able to experience an improved quality of life. ■