Humanitarian Device Exemption Allows IBV(R) Valve System As Minimally Invasive Treatment Alternative for Patients with Prolonged Post-Operative Air Leaks.
Spiration, Inc., a developer of novel medical devices designed to benefit patients with acute and chronic conditions of the lung, announced that the company has received Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) for the use of its minimally invasive IBV® Valve System 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. This FDA approval represents the first for a bronchial valve implant for the lungs.
“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.”
Conventional treatments for prolonged air leaks include further surgical intervention, the insertion of drain tubes into the chest, or lung tissue sealing (pleurodesis). These approaches can result in additional complications, prolonged hospitalization, restricted ambulation, significant pain, and increased costs. The IBV Valve System provides a non-surgical, minimally invasive alternative to existing treatments.
The FDA HDE approval of the IBV Valve System is based on results from 58 patients enrolled in a U.S. IDE study of the device for the treatment of emphysema and four patients treated with the IBV Valve System for prolonged air leaks under IDE compassionate use exemptions. The effectiveness of the device for this use has not been demonstrated.