Spiration IBV Bronchial Valve Gets FDA OK

IBV™ Valve, the Intra-Bronchial Valve from Spiration, Inc. of Redmond, Washington, has been given Humanitarian Device Exemption (HDE) approval from the FDA “to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged,following lobectomy, segmentectomy, or lung volume reduction surgery.” We’ve been following this device since 2005, and had a report earlier this month on the European approval of this device for precisely the same indications.

“This FDA approval, the first for a lung device in recent memory and the first ever for a bronchial valve, is an exciting milestone and marks an advancement toward broader FDA approval of devices to treat various types of lung conditions,” said Rick Shea, president and CEO, Spiration®. “As one of only three HDE approvals so far in 2008, this approval is a significant accomplishment for Spiration.”
“Although rarely life threatening, prolonged post-operative air leaks can be a significant and costly complication of lung surgery,” said Daniel Sterman, M.D., director of Interventional Pulmonology at the University of Pennsylvania Medical Center in Philadelphia. “The HDE approval of the IBV Valve System will have a positive impact on the lives of patients who are having difficulty recovering from lung surgery. We are pleased that this approval provides a new treatment alternative for these patients.”

Press release: Spiration, Inc. Receives First FDA Approval for Bronchial Valve Humanitarian Device Exemption Allows IBV® Valve System As Minimally Invasive Treatment Alternative for Patients with Prolonged Post-Operative Air Leaks
Product page: IBV Valve
Flashbacks: Spiration IBV Valve Shows Promise in Treatment of Persistent Air Leaks; IBV™ Valve: Intra-Bronchial Device for Emphysema; IBV™ Valve Might Prevent Surgery for Some