Spiration, Inc out of Redmond, Washington received European approval to market the company’s IBV™ Valve, an intra-bronchial device designed for the treatment “of diseased and damaged lung, an indication that includes the treatment of emphysema and the resolution of air leaks,” according to the company. In addition, the firm is also reporting positive results from a small US compassionate use study of the device. We’ve been reporting about the Intra-Bronchial Valve (IBV™ Valve) since 2005. (Previously: IBV™ Valve: Intra-Bronchial Device for Emphysema; IBV™ Valve Might Prevent Surgery for Some.) The main idea behind the device is an improvement of a balance between ventilation and blood perfusion in the lungs, by blocking entrance of the air into diseased regions, and also by preventing air escape from air leaks.
From a press release obtained by Medgadget:
Daniel Sterman, M.D., director of Interventional Pulmonology at the University of Pennsylvania Medical Center in Philadelphia, presented an evaluation of the compassionate use of the IBV Valve System for the treatment of air leaks in six patients during this week’s ERS Annual Congress.
Air leaks are a common complication of surgery caused by lung tissue that has not completely closed and sealed, resulting in an accumulation of air in the chest that can cause breathing difficulties. They can also result from serious diseases of the lung and contribute to significant morbidity and mortality.
“In these very complex compassionate use cases, the IBV Valve System was safe and effective for the treatment of air leaks,” said Dr. Sterman. “I believe this is a very promising clinical application for this device.”
The U.S. Food and Drug Administration’s (FDA) compassionate use provision allows access for patients who do not meet the requirements for inclusion in clinical investigation but for whom the physician believes the device may provide a benefit in treating and/or diagnosing their disease or condition.
The IBV Valve System is a minimally invasive treatment that has diverse applications for both acute and chronic conditions of the lung. In Europe, the system has received market clearance through CE Mark for diseased and damaged lung, a broad indication that includes the treatment of emphysema and the resolution of air leaks, a complication that can occur following lung surgery or as a consequence of certain serious lung diseases.
During the minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the bronchial tubes through the mouth or nose) to deploy the small umbrella-shaped valves into the airways of the lungs. The valves are designed to be easily removed via a similar bronchoscopic procedure.