Pulmonx Endobronchial Valve (EBV) Therapy Demonstrates Safety and Significant Long-Term Benefit in French Study
- On April 24, 2014
April 24, 2014, Neuchâtel, Switzerland – Pulmonx, an emerging leader in interventional pulmonology, announced today that its Zephyr® Endobronchial Valve (EBV) was featured at the 18th World Congress for Bronchology and Interventional Pulmonology (WCBIP) in Kyoto, Japan in the poster presentation titled “Long-term outcomes in 35 consecutive patients with emphysema after endoscopic lung volume reduction with Zephyr® valves.”
Cécile Bosc, MD, Department of Pneumology, CHU Grenoble, Joseph Fourier University presented the results of a study using the Chartis Pulmonary Assessment System and Zephyr® EBV to treat emphysema patients between January 2008 and July 2013.
The interim results of this ongoing study evaluated long-term outcomes after treatmentwith Zephyr® valves in 35 consecutive patients who were followed for a median of 15.8 months, ranging in follow-up from 1-month to 68 months. The survival rate in the entire cohort was constant at 77.3% at both 15 and 68 months follow-up. In addition, the results showed that patients who achieved atelectasis experienced statistically significant lung function improvement at 1-year which was sustained through subsequent follow-up.
Co-author Prof. Christophe Pison, MD, also of CHU Grenoble, Joseph Fourier University, who designed the study and led the team of researchers, stated “EBV therapy using the combination of Chartis and Zephyr® has shown to provide significant long term clinical benefit.”
The authors concluded that lung volume reduction using Zephyr® valves has an acceptable safety profile and when atelectasis is achieved, significant improvements in Pulmonary Function Tests are observed. This marks the third single center series showing sustained survival rate and significant long-term clinical benefit of the Zephyr® EBV therapy.
The Zephyr® Endobronchial Valve is a minimally invasive device intended to treat patients with emphysema. Emphysema patients suffer from hyperinflation, an increase in volume of the diseased portions of their lungs, which then compresses the healthier areas. The Zephyr® EBV therapy involves bronchoscopic placement of one-way valves designed to reduce the hyperinflation in the diseased portion of the lungs, thereby improving the ability of the healthier portions of the lungs to function. The Zephyr® EBV received the CE Mark in 2003. Since becoming commercially available in Europe and select countries worldwide, the company estimates that it has been used to treat over 7,500 patients.
The Pulmonx Chartis Pulmonary Assessment System provides pulmonologists with lobe-specific information about a patient’s lung, enabling 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 Pulmonx Chartis assessment now ensures that a very high percent of treated patients will experience benefit from EBV treatment. The Chartis Pulmonary Assessment System and accessories are FDA 510(K) cleared devices.
Pulmonx, based in Redwood City, California, and Neuchâtel, Switzerland, is focused on developing and marketing minimally invasive medical devices and technologies for the diagnosis and treatment of pulmonary disorders.
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