Pulmonx said earlier this month that a sham-controlled trial of its Zephyr endobronchial valve met and exceeded its primary endpoints, reporting a 20.9% average improvement in lung function.
The Believer-Hifi study, published in The Lancet, is the 1st successful sham-controlled trial of any invasive emphysema device, Redwood City, Calif.-based Pulmonx said.
“We have been able to show, for the 1st time in a rigorous randomized controlled trial, that endobronchial valves can improve lung function and exercise capacity and achieve similar results to those seen with lung volume reduction surgery in properly selected patients. In the study, we also saw that likely responders identified with the Chartis system experienced better outcomes than those selected with CT visual assessment alone,” chief investigator Dr. Nick Hopkinson said in a press release.
The Zephyr is a 1-way valve placed in the lungs to block airflow to diseased regions of the lung to achieve lung volume reduction, Pulmonx said. The device has been implanted in more than 10,000 patients globally.
“An ever-growing body of evidence supports the benefits of the Zephyr EBV in improving breathing and quality of life for patients. These data also demonstrate the benefit of the combined use of the Chartis system and Zephyr valves,” CEO Glen French said in a press release.
In December, Pulmonx tapped ex-Asthmatx exec Glen French as its new CEO. French was the co-founder, president & CEO of Asthmatx, which developed the Alair bronchial thermoplasty treatment for asthma. Boston Scientific bought Asthmatx in a 2010 deal worth $443.5 million,