In short
Interventional Pulmonology company Pulmonx has announced that the European Respiratory Journal has published the results of the Chartis Multi-Centre study, the first to combine the Chartis Pulmonary Assessment System and Zephyr EBV (EndoBronchial Valve) treatment for patients with advanced emphysema.
The published results of the study demonstrate that in patients who achieve volume reduction post Endobronchial Valve treatment, the majority get clinically significant responses in lung function, exercise tolerance and quality of life measures.
Background
Over 30 million patients have been diagnosed with emphysema, a form of chronic obstructive pulmonary disease (COPD) that occurs when the air sacs in the lungs are gradually destroyed, leading to shortness of breath even while at rest. COPD is a major cause of disability and a major public health problem, ranked by the World Health Organisation as the fourth leading cause of death today and it is expected to become the third leading cause of death worldwide by 2030s.
Most patients suffering from emphysema currently have few options for treatment, although surgical lung volume reduction is practiced by a small number of specialist centres.
Pulmonx, describing itself as an emerging leader in interventional pulmonology, develops and markets minimally-invasive medical devices and technologies for the diagnosis and treatment of pulmonary disorders. The Chartis System and Zephyr EBV is the first effective diagnostic and therapeutic solution to the problem of emphysema-induced hyperinflation.
Zephyr endobronchial valves can reduce volume in the diseased portion of the lungs thereby improving the ability of the healthier portions of the lungs to function, and relieving the patient’s symptoms, as well as allowing patients to increase their activity levels, promoting better overall health.
According to Pulmonx, previously published studies on the Zephyr EBV have confirmed the safety of the treatment, as well as its effectiveness in a subset of emphysema patients. The challenge in applying the therapy to a broad population of emphysema patients has been the ability of physicians to plan valve treatments to account for anatomical variations in the lungs of individual patients which impact the effectiveness of the valves. The addition of the Chartis assessment now ensures that a very high percent of treated patients will experience benefit from EBV treatment. The Chartis system is a diagnostic tool in establishing the existence or extent of collateral ventilation, a condition which mitigates against success of Zephyr Valve therapy.
Clinician comments
“Using the Chartis system to reliably plan EBV treatment can provide very real benefits for emphysema patients by relieving the hyperinflation and providing clinical benefit. This is a welcome advance for patients who have very few treatment options available to them” said Professor Felix Herth, MD, PhD., FCCP, Chairman and Head of Pneumology and Respiratory Care at Thoraxklinik, University of Heidelberg, Germany. “I believe that the publication of the results of the study will lead to Chartis and EBV treatment becoming a standard-of-care in the management of emphysema,” he continued.
The study
The peer-reviewed clinical paper, “Radiological and Clinical Outcomes of Using Chartis to Plan Endobronchial Valve Treatment,” demonstrates the ability of the bronchoscopic Chartis Pulmonary Assessment System to predict treatment response by determining the presence or absence of collateral ventilation (CV). In this study performed in Germany, The Netherlands and Sweden, 80 patients underwent a Chartis assessment prior to Zephyr endobronchial valve implantation. The patients predicted by Chartis to respond showed statistically significant target lobe volume reduction and associated improvement in lung function compared to those predicted not to respond.
There were no serious adverse events related to the Chartis System. Six patients experienced a pneumothorax, a known temporary complication of EBV therapy, and recovered with standard treatment with all patients demonstrating significant target lobe volume reduction.
The study highlights that the addition of the Chartis System to plan EBV therapy produces consistent, clinically meaningful results in a broad population of patients with emphysema, while also confirming the safety profile of Zephyr EBV therapy in treatment of emphysema.
Company comments
“This publication is a milestone for us as it documents the safety and efficacy of Chartis guided Zephyr EBV therapy. It is particularly useful to have this peer-reviewed data published in the public domain as we make final preparations to begin our US trial,” commented Michael A. Baker, President and CEO of Pulmonx.
Source: Pulmonx, Business Wire
Note: The Zephyr EBV is an investigational device in the United States and as such limited by U.S. law to investigational use. The Chartis System is for use/sale outside the United States only.
published: May 14, 2012 in: Clinical Studies/Trials, Thoracic/Respiratory