FDA panel votes against BTG ’ s PneumRX Elevair

An FDA advisory committee panel yesterday voted against approving BTG‘s PneumRX’s Elevair endobronchial coil system intended for treating patients with severe emphysema. The panel voted 7 to 5 in favor of the device’s safety, but 8 to 3 that the benefits do not outweigh the risks, and 5 to 7 that the device was effective for use with patients in its proposed indications. The Elevair device is a nitinol endobronchial coil intended to be deployed bronchoscopically to reduce lung volume in patients with severe emphysema. The company submitted an application for premarket approval with the FDA, backed by clinical evidence from a trial of the device. The assessor blinded, prospective, randomized, multi-center Renew trial examined the use of the device over a year, and included four years of additional follow-up visits with 315 subjects. Results from the trial indicated a statistically significant improvement at 12 months in its primary effectiveness endpoint, but there was a “loss of treatment effect beyond 12 month,” according to the FDA. In its pivotal trial, which examined the system in 114 patients, of the 81% patients who completed the 2 year and 39% that completed the 3-year visit, results from the six minute walk test showed a decline of 17.2 meters and 39.3 meters, respectively. Forced expiratory volume in one second results were also similar to baseline at 2 and 3 years, the FDA said. The most common adverse events in the trials in both the treatment and...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Respiratory BTG Source Type: news