Medical devices maker Pulmonx has reported positive data from a US pivotal trial (LIBERATE) conducted to evaluate the use of its Zephyr Endobronchial Valve to treat severe emphysema, an advanced form of chronic obstructive pulmonary disease (COPD).
Zephyr is an investigational, tiny, one-way valve designed to be implanted in target airways of the lungs to occlude the more diseased areas, in turn decreasing hyperinflation and facilitating better functioning of healthier parts.
Emphysema is characterised by a shortage of breath despite regular use of COPD medications and/or oxygen.
Results revealed that the LIBERATE trial met all primary and secondary endpoints involving various assessments of breathing and quality of life following one year of treatment.
Trial lead investigator Gerard Criner said: “The LIBERATE Study definitively proves that Zephyr Valves offer clinically meaningful improvements in three important areas for patients – the ability to breathe better, be more active, and enjoy an improved quality of life.
“The Zephyr Valve also demonstrated an acceptable safety profile given the magnitude of benefit seen in this study.”
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The multi-centre, randomised, controlled trial was designed to investigate the safety and effectiveness of the Zephyr Valve in 190 patients suffering from severe heterogeneous emphysema and having little to no collateral ventilation in the target lobe.
Conducted at 24 clinical sites, the trial compared the endobronchial valve with medical management.
It was observed that more patients in the device-treated group experienced target lung function improvement, compared to medical management alone.
In addition, participants treated with Zephyr were able to perform more daily activities and experienced a statistically significant decrease in respiratory failure rate with indications for a reduction in the rate of COPD hospitalisations.
The most common side effect observed during the trial was pneumothorax that required no intervention or standard medical management in certain cases.