Pulmonx®, Inc. says results of two multi-center, randomized clinical trials show clinically meaningful improvements in lung function after treatment with the Zephyr® Endobronchial Valve (EBV) in emphysema patients without collateral ventilation.
Background
Frequent visitor to our pages, Zephyr’s innovative Endobronchial Valves are tiny, minimally-invasive, one-way valves placed via a flexible bronchoscope in airways of the lungs to occlude diseased regions and reduce lung hyperinflation. As a result, the remaining healthier regions can function more efficiently, enabling better breathing and an improved quality of life for patients.
Six-month data from both the TRANSFORM and IMPACT trials, presented at the American Thoracic Society international conference, demonstrate that Zephyr valves provide positive benefits in these patients with either homogeneous or heterogeneous distribution of emphysema.
The results are consistent with two prior randomized controlled trials of the Zephyr valve in patients without collateral ventilation which also support the ability of Zephyr valves to significantly improve lung function, exercise tolerance and quality of life.
Investigator comments
“The magnitude of benefits to patients in this pan-European trial are dramatic and reinforce results published from prior single center studies,” said Samuel Kemp, MD, principal investigator and respiratory physician at the Royal Brompton Hospital, London, UK. “Using Chartis for patient selection enabled us to accurately identify patients without collateral ventilation, which is a key predictor for good outcomes with this device.”
Company comments
“For patients with severe emphysema, there were previously few therapeutic options,” said Pulmonx Chief Executive Officer Glen French. “Now, we have consistent data from four randomized studies showing that, regardless of disease heterogeneity, when patients are selected for the absence of collateral ventilation, they can gain substantial benefits in quality of life, exercise capacity and lung function with Zephyr valves.”
Source: Business wire. Full release here.
published: May 24, 2017 in: Clinical Studies/Trials, Thoracic/Respiratory