Temple University Hospital has become the first U.S. center to perform bronchoscopic lung volume reduction using implantation of the Zephyr® Endobronchial Valve (Zephyr® EBV®) to treat severe emphysema following U.S. FDA approval.
Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University (LKSOM) and Director of the Temple Lung Center, and his Lung Center team completed the 45-minute procedure on August 10.
"This first procedure post-FDA approval is a turning point in our capabilities to treat severe emphysema using a minimally invasive bronchoscopic option," Dr. Criner said. "We are very excited to be able to clinically offer this therapy to patients with severe emphysema who remain symptomatic despite optimal medical care."
Temple Lung Center was selected by the Pulmonx Corporation as a national clinical center of excellence - the only one in the United States - for peer instruction in selection and performance of bronchoscopic lung volume reduction. August 9 marked the first-ever day of training in the nation for pulmonologists who wanted to learn how to perform bronchoscopic lung volume reduction using the Zephyr® valve. In collaboration with Pulmonx, the California-based manufacturer of the Zephyr® EBV®, pulmonologists from New York's Columbia Presbyterian Hospital, the University of Michigan Medical Center, Banner Health in Phoenix, Arizona, and the University of Chicago Medical Center, received instruction on the care and management of endobronchial valve placement at the Temple Health Sciences Center Campus. The next training is scheduled to take place on September 28 at Temple.
"It is an incredible honor for Temple Lung Center to be recognized in this way and to work with colleagues and peers from across the country to help our patients with emphysema live fuller, happier and more active lives," Dr. Criner added.
Lung volume reduction surgery for treatment of emphysema is beneficial but can be invasive and risky in some. The Zephyr® EBV® now provides an alternative option for patients with emphysema and suffering from hyperinflation. The Zephyr® EBV® is placed using a bronchoscope and flexible delivery catheter and then functions as a one-way valve causing the damaged lobe of the lung to deflate, while preventing further lobar inflation. This reduces hyperinflation, which happens when air becomes trapped in the lungs and makes breathing difficult for emphysema patients.
The FDA granted pre-market approval to the Zephyr® EBV® on June 29 under its breakthrough devices designation. This approval followed a study published in May by Dr. Criner and a Temple University Hospital-led research team that found the implantation of the Zephyr® EBV® successfully reduced shortness of breath and improved lung function and quality of life, with benefits lasting at least one year post-intervention for patients with severe emphysema. That clinical trial was known as LIBERATE.
In the LIBERATE trial, which included 190 patients, almost half of the patients treated with Zephyr® EBV® experienced improved lung function, compared with just 17 percent of patients treated with current standard medical management approaches for emphysema.
Moreover, patients who received the Zephyr® therapy continued to experience clinical benefits 12 months after receiving treatment compared to the control group. Side effects related to the intervention were considered acceptable relative to the clinical gains observed for the treated population.
Key to the success of the LIBERATE trial was proper patient selection. In LIBERATE and smaller previous trials, Zephyr® was found to be effective in patients who exhibited little to no collateral ventilation, a phenomenon in which air moves around obstructed lung tissues via channels that bypass the normal airways.