The U.S. Food and Drug Administration has given Humanitarian Device Exemption (HDE) approval to Spiration, Inc. to use its IBV® Valve System for controlling air leaks which may become prolonged after procedures such as lung volume reduction surgery. This is the first approval from FDA for a bronchial valve implant for the lungs. Conventional treatments such as surgery can lead to complications and are expensive. This minimally invasive system is a safer and cheaper alternative.

Spiration, Inc. has made an announcement that its IBV® Valve System has been launched by Olympus in the European markets. The minimally invasive device is used for the treatment of various chronic lung problems. The system has already received the CE Mark for use in the treatment of serious diseases of the lung such as emphysema. Initially, the device will be presented to select physicians of Europe. The system may prove to be a boon for  patients who can not or do not undergo surgical operation. Spiration® will continue with manufacturing while Olympus does the distribution.