- On May 10, 2012
Zephyr® Endobronchial Valve (EBV) therapy guided by Chartis®Assessment is effective in a broad range of patients.
May 10, 2012 ,Peseux, Switzerland, Pulmonx, an emerging leader in interventional pulmonology, announced today that the European Respiratory Journal has published the results of the Chartis®Multi-Centre study. The study is the first to combine the Chartis® Pulmonary Assessment System and Zephyr® EBV 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. After detailed review of the U.S. and European VENT data, a much broader profile of patient characteristics was identified for potential inclusion; including patients that would have been excluded in the previous studies.
“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”.
“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.
About the European Respiratory Journal publication
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.
“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.
The publication is available online at erj.ersjournals.com/content/early/2012/05/02/09031936.00015312.abstract
Emphysema is 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. Globally over 30 million patients have been diagnosed with emphysema. COPD is a major cause of disability and a major public health problem. The World Health Organization ranks it 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. Emphysema is a major economic problem and a burden on the global healthcare system, due to millions of workdays missed, expensive and minimally effective therapies and frequent hospitalisations related to the disease.
About the Chartis® and Zephyr® Technologies
Emphysema patients suffer from hyperinflation—an increase in volume of the diseased portions of their lungs, which then compresses the healthier areas. This results in breathlessness and costly disability. Many patients cannot carry out even the most basic activities of everyday living, and may require supplemental oxygen. 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.
Some patients have extra airflow pathways between the lobes of their lungs, a condition known as “collateral ventilation”. Large amounts of collateral ventilation can prevent the valves from working effectively by circumventing them. The Chartis® System includes a balloon catheter that is inserted into the airway and a simple, easy-to-use console that displays expiratory airflow, pressure and resistance, providing a quantitative measure of collateral ventilation.
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.
Pulmonx, based in Redwood City, CA, and Peseux, Switzerland, is focused on developing and marketing 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.
The Zephyr® EBV is an investigational device in the United States. Limited by U.S. law to investigational use. The Chartis® System is for use/sale outside the United States only.
Michael A. Baker, President & CEO
Peseux, Switzerland, Phone: +41 32 557 5800
Redwood City, CA, Phone: +1 (0) 650 216-0150
Source Business Wire: www.businesswire.com/news/home/20120510006766/en