A potential treatment that could allow a greater number of severe COPD and emphysema patients to be treated with minimally-invasive Zephyr Valves is being tested on its first patient as part of the CONVERT II Pivotal Trial.
Pulmonx, manufacturer of the AeriSeal system, said the trial is a multicenter, international study evaluating the safety and effectiveness of the system in limiting collateral ventilation in severe COPD and emphysema patients. Collateral ventilation is caused by openings in the lung fissures, and the AeriSeal system is designed to close these openings in a lobe targeted for bronchoscopic lung volume reduction, thus blocking collateral ventilation.
Successful treatment with the AeriSeal system is followed by treatment with the Zephyr Valves.
The goal of the CONVERT II Pivotal Trial is to establish the safety and effectiveness of using the AeriSeal system to target and treat the fissural defects that allow collateral ventilation between lung lobes. Procedural success — clinical parameters including lung function, quality of life and exercise capacity — will be evaluated at six months post-valve treatment. Those results will then be used to support a Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA).
Ultimately, the trial will be rolled out to approximately 200 patients at up to 30 sites in the United States, Australia and Europe.
