A new research trial has been launched at The University of Louisville to investigate the effectiveness of a medical device designed to help treat emphysema patients by shutting off the portion of the lung affected by the disease. UofL is the only Kentucky site among 14 testing the new device nationwide.
In emphysema, diseased lung regions over-inflate, making breathing difficult. A minimally invasive approach to lung volume reduction developed by Pulmonx to manage hyperinflation, the Zephyr Endobronchial Valve (EBV), incorporates a one-way, silicone, duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer covered with a silicone membrane that blocks off diseased lung sections to inhaled air, but still allows trapped air already inside the area to escape. With each respiratory cycle, the amount of air in the target lung segment is reduced. The valve is designed to be a permanent implant. The EBV is intended to predict and achieve reduction of volume in the diseased portion of the lung, without the risks and complications of surgery, and the Valve is designed to be a permanent implant.
EBV therapy involves performing an assessment of the patient’s hyperinflated lobes for presence of collateral ventilation, or airflow within or between the lung’s lobes — then placing small, one-way valves in the targeted airways to direct the airflow out of diseased portions of the lung. According to Pulmonx, a typical procedure involves a Chartis assessment (a proprietary pulmonary diagnostic tool that allows physicians to identify which patients are appropriate for the Zephyr valve procedure), which typically takes about 5 minutes per lobe; then placement of three to four valves in the target lobe using a flexible delivery catheter with a camera on the end (bronchoscopy), which takes approximately 10 to 30 minutes to complete. With bronchoscopy, the surgeon can reach lung airways by passing the tube through either the mouth or nose, obviating the need for invasive surgery. This intervention enables the diseased part of the lung to collapse, allowing healthier parts to expand.
Pulmonx reports that patients after undergoing the procedure experience significant lung function improvement, better exercise tolerance, and improved quality of life, as well as long-term survival benefits through five years.
Emphysema, an ongoing, progressive disease of the lower respiratory tract in the lungs, is one of the two main types of chronic obstructive pulmonary disease (COPD). Emphysema causes airway blockage resulting in shortness of breath, chronic productive coughing that produces large amounts of mucus, chest tightness and/or wheezing and other symptoms. Laboring to breathe can limit activity, diminish quality of life and put extra strain on the heart. U
The randomized study at UofL and the other participating institutions, known as the LIBERATE study, is investigating EBV’ therapy’s safety and effectiveness for treatment of emphysema symptoms compared with current standard COPD therapy alone. Tanya Wiese, D.O., director of the Interventional Pulmonary Program, is principal investigator of the study at UofL.
“The Zephyr EBVs novel mechanism of action shows promise to help the healthy parts of the lung expand and reduce the effect of the disease,” Dr. Wiese observes. “While not a cure, we believe this device could bring relief and improved quality of life to our patients with emphysema.”
There is particular interest in problem of emphysema at UofL because of a high incidence of the disease in Kentucky. A UofL release cites American Lung Association estimates that more than 56,000 Kentuckians — a whopping 13 percent of the population — have emphysema, one of the highest rates of anywhere in the United States.
The other trial sites include Arizona Pulmonary Specialists, Cleveland Clinic, Duke University Medical Center, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Southern Illinois University School of Medicine, Temple University Hospital, University of Alabama at Birmingham, Beth Israel Deaconess Medical Center, University of Pittsburg Medical Center, The Mayo Clinic, University of California at Davis Medical Center, University of California, San Francisco and University of Southern California.
Study enrollment in is anticipated to be completed by year-end 2015. Participating patients will be followed for three years. Additional information on the LIBERATE study is available on the national clinical trials website, ClinicalTrials.gov, using the Clinical Trials Identifier NCT01796392 or by calling 1-888-248-LUNG.
The study is sponsored by Pulmonx Inc., a multinational pulmonology-focused medical device developer and manufacturer with U.S. headquarters located in Redwood City, California.
The University of Louisville
U.S. Food and Drug Administration
The University of Louisville