The IBV Valve System for Treating Emphysema is Investigational and Not Approved in the United States.
More than four million Americans are living with emphysema, a chronic condition that makes breathing difficult and severely impacts quality of life. Currently available treatments for emphysema include medications, home oxygen therapy, pulmonary rehabilitation, lung volume reduction surgery and lung transplantation.
In the United States, the IBV Valve System is not approved by the FDA for the treatment of emphysema, but is subject to ongoing clinical investigation in which approval for emphysema will be sought.
CAUTION: INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.