New England Journal of Medicine and European Respiratory Society Congress Document Performance of Pulmonx’s Zephyr EBV Treatment
Pulmonx, an emerging leader in interventional pulmonology, announced today that the New England Journal of Medicine has published the results of the largest prospective, randomized, controlled study completed to date of endobronchial approaches to emphysema treatment, the VENT Study (Endobronchial Valve for Emphysema PalliatioN Trial). The published results of the VENT Study highlight the potential of the Pulmonx Zephyr Endobronchial Valve (EBV) to improve the lives of patients suffering with certain types of emphysema. In the days leading up to the publication, several physician investigators also presented results of the European arm of the study, known as EURO-VENT, at the annual meeting of the European Respiratory Society (ERS) in Barcelona, Spain. The EURO-VENT data confirmed most of the positive results of the U.S. VENT Study and offered new analyses that highlight significant clinical benefits linked to target lung lobe volume reduction.
About the New England Journal of Medicine publication
The original peer-reviewed article, “A Randomized Study of Endobronchial Valves for Advanced Emphysema,” details the results of the multi-center, prospective, randomized study of the use of the Zephyr EBV for the treatment of certain types of emphysema. The study results highlight the excellent safety profile of the Zephyr EBV especially when complications of alternative treatments such as lung transplantation or lung volume reduction surgery are considered, and confirm that the procedure can result in significant improvements in well selected patients.
“We’re extremely pleased that the New England Journal of Medicine has decided to publish the results of the U.S. VENT trial. Our heartfelt congratulations on this seminal research accomplishment go out to Dr. Sciurba at the University of Pittsburg Medical Center and all the study authors and investigators who collaborated in the trial,” commented Michael A. Baker, President and CEO of Pulmonx, the manufacturer of the Zephyr valve.
About the ERS Presentations
The ERS conference last week featured a broad array of posters, oral presentations, and exhibitions describing various studies and approaches to minimally invasive treatment of emphysema, a testament to the growing clinical interest in the field of interventional pulmonology. Prof. Felix Herth (Thoraxklinik, Heidelberg) and Dr. Armin Ernst (St. Elizabeth Medical Center, MA) presented and discussed for the first time in any venue the results of the EURO-VENT trial. In addition to highlighting similarities in results between the U.S. and European cohorts, the presenters described a group of “high responders” in EURO-VENT, defined as treated patients with significant target lobe volume reduction (≥55%). These “high responders” showed impressive improvements in key physiologic and clinical measures, strengthening the rationale for unilateral lobar volume reduction as a treatment goal. The presenters also noted that the “high responders” included a mix of upper-lobe and lower-lobe patients and high- and low-heterogeneity patients, suggesting the possibility that a broader emphysema patient population may benefit from EBV therapy.
According to Dr. Ernst, “Although we defined ‘high responders’ as patients with ≥55% target lobe volume reduction, it is likely that patients may benefit from smaller reductions in target lobe volume.” The presented EURO-VENT data also highlight the importance of achieving lobar exclusion (isolating the target lobe through accurate EBV placement) and confirming lack of collateral ventilation (non-airway channels that prevent target lobe emptying) as key factors in enabling successful EBV volume reduction. Pulmonx’s Chartis Pulmonary Assessment System quantifies collateral ventilation in target lobes and segments of the lung and is used at the Thoraxklinik and other hospitals in Europe for evaluating collateral ventilation in EBV procedures.
“A direct measure of collateral ventilation that can be performed in the pulmonology suite is needed for EBV procedures,” said Dr. Herth. “We believe the Chartis system is the right tool to provide this critical information.”
“The quality, diversity, and consistency of the scientific work we’re seeing presented at this meeting is a direct reflection of the high level of excitement we’re seeing in the marketplace,” said Mike Baker. “After a decade of work, it is extremely gratifying for Pulmonx to confirm that we have a treatment that produces significant improvements for a large segment of the huge patient population that suffers from the devastating disease of emphysema. We believe we have the opportunity to help even more patients over time, and we intend to aggressively pursue the research and development work that will make that opportunity a reality.”
Pulmonx is working with key clinicians on protocols to evaluate treatment algorithms using the Chartis Pulmonary Assessment system and expand the use of its Zephyr EBV based on these results.
Emphysema is a form of chronic obstructive pulmonary disease (COPD), a major cause of disability and the fourth leading cause of death in the U.S. In 2007, the economic burden of COPD was $42.6 billion in healthcare costs and lost productivity in the U.S. alone. COPD is expected to be the fourth leading cause of death worldwide by 2030 due to increasing rates of smoking and aging demographics in many countries. Patients suffering from emphysema currently have few options for treatment beyond lung volume reduction surgery, a very costly, invasive, and irreversible procedure with high morbidity and mortality.
About Pulmonx (www.pulmonx.com)
Pulmonx, based in Redwood City, CA, is focused on developing and marketing minimally-invasive medical devices and technologies for the diagnosis and treatment of pulmonary disorders.
About the Products
The Pulmonx Chartis Pulmonary Assessment System provides pulmonologists with lobe-specific information about a patient’s lung, leading to more informed treatment decisions. The system’s first clinical application is direct quantification of collateral flow, or intra-lobar airflow in documented in numerous peer reviewed publications. However, recent research has demonstrated that collateral flow can limit the effectiveness of endobronchial lung volume reduction (ELVR) therapy in some patients. Thus, the combined solution of Chartis screening and Zephyr treatment represents a potentially significant breakthrough in the treatment of late-stage emphysema. The early experience with this combined approach is being heralded in the clinical community as a potentially significant advance in the standard-of-care.