An FDA advisory panel voted against the approval of BTG's Elevair endobronchial coil system for the treatment of people with severe emphysema.
The panel decided the device is safe for use in patients who meet the criteria specified for the proposed indication while considering the additional procedures needed to maintain the effectiveness of the coil system. However, the panel decided there is not reasonable assurance that Elevair is effective for use for those patients, and that the benefits of the system do not outweigh the risks.
FDA will consider the panel's recommendation in its ongoing review of the pre-market approval application for the coil system, which is expected to conclude later this summer. The company said it plans to work with the agency to address the specific concerns the advisory panel raised. They Elevair system is called the PneumRx coils in Europe.
In Europe, BTG has initiated the ELEVATE study that is designed to support patient selection and market development of the coil system.