In the view of an expert panel, published in Respiration only the Pulmonx® 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.
Background
Long-followed on our pages, and now with over 10,000 patients under its belt, Pulmonx’s Zephyr EBV is a tiny, one-way valve placed in the lungs to block airflow to diseased regions in order to achieve lung volume reduction by exclusion. The diagnostic tool known as the Chartis® System is utilized immediately prior to the Zephyr EBV procedure to identify those patients with low or no collateral ventilation, who are the most likely to respond to the treatment.
The 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. 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.
Investigator comments
The expert panel of pulmonologists, hailing from Germany, Netherlands and UK, stated 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.”
They also noted 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.”
Source: Pulmonx
published: March 10, 2016 in: Clinical Studies/Trials, Thoracic/Respiratory