Gerard J Criner, Antoine Delage, Kirk Voelker, D Kyle Hogarth, Adnan Majid, Michael Zgoda, Donald R Lazarus, Roberto Casal, Sadia B Benzaquen, Robert C Holladay, Adam Wellikoff, Karel Calero, Mark J Rumbak, Paul R Branca, Muhanned Abu-Hijleh, Jorge M Mallea, Ravi Kalhan, Ashutosh Sachdeva, C Matthew Kinsey, Carla R Lamb, Michael F Reed, Wissam B Abouzgheib, Phillip V Kaplan, Gregory X Marrujo, David W Johnstone, Mario G Gasparri, Arturo A Meade, Christopher A Hergott, Chakravarthy Reddy, Richard A Mularski, Amy Hajari Case, Samir S Makani, Ray W Shepherd, Benson Chen, Gregory E Holt, Simon Martel
Rationale: Less invasive, nonsurgical approaches are needed to treat severe emphysema. Objectives: To evaluate the effectiveness and safety of the Spiration Valve System (SVS) versus optimal medical management. Methods: In this multicenter, open-label, randomized, controlled trial, subjects aged 40 years or older with severe, heterogeneous emphysema were randomized 2:1 to SVS with medical management (treatment) or medical management alone (control). Measurements and Main Results: The primary efficacy outcome was the difference in mean FEV1 from baseline to 6 months...
December 1, 2019: American Journal of Respiratory and Critical Care Medicine