An expert panel recommendation published in Respiration concluded that only Pulmonx’s minimally-invasive Zephyr Endobronchial Valve (EBV) and invasive lung volume reduction surgery (LVRS) “reached the evidence level to be used outside of clinical trials” for the treatment of severe emphysema.
The Zephyr EBV (which is limited to investigational use only in the US) is a tiny, one-way valve placed in the lungs to block airflow to diseased regions in order to achieve lung volume reduction. The device has been implanted globally in more than 10,000 patients, according to Pulmonx.
The panel’s findings were based on a systematic review and meta-analysis of clinical evidence to date for six different therapies: LVRS, EBV, coils, intra-bronchial valves (IBV), thermal vapor ablation (steam) and biological lung volume reduction.
According to a Pulmonx press release, the Zephyr EBV is the best studied of these options to-date, with three completed randomized controlled trials: STELVIO, BeLieVeR-HIFi, and VENT. These studies have demonstrated significant improvements in lung function, exercise capacity and quality of life in patients who are treated with the Zephyr EBV, with greater benefit in patients with low collateral ventilation, according to Pulmonx.
In the expert panel recommendation, the authors also note that two small long-term series have been published on the valves, both of which showed “a significant survival benefit in the successfully treated compared to the unsuccessfully treated group.”
In the expert panel recommendation in Respiration, the authors state that, “when taking all these trials together evidence is accumulating that with EBV treatment, real personalized medicine for the treatment of patients with severe emphysema is possible, with even as high as a 75 percent responder rate to treatment when using a combined approach for recruiting potential candidates: assessment of fissure integrity to preselect patients, and (confirmation) of the absence of collateral flow with (the) Chartis (System).” In addition, the Panel reiterated that valves remain “the only removable endoscopic lung volume reduction technique.”