Experts Recommend Zephyr EBV as Only Minimally Invasive Emphysema Treatment for Use Outside Clinical Trials

Pulmonx, based in Redwood City, California, recently announced the publication of recommendations from a panel of experts offering broad guidance regarding selection of therapies for patients with advanced emphysema. The panel recommended that only Pulmonx’s Zephyr Endobronchial Valve (EBV) and invasive lung volume reduction surgery (LVRS) “reached the evidence level to be used outside of clinical trials” to treat severe emphysema.

The report in the journal Respiration was titled “Endoscopic Lung Volume Reduction: An Expert Panel Recommendation.” Results were based on an extensive systematic review and meta-analysis of the available clinical evidence for six treatments: thermal vapor ablation (steam), LVRS, EBV, coils, intra bronchial valves (IBV), and biological lung volume reduction.

The Zephyr one-way valve blocks airflow to the diseased region of the lung, allowing healthy regions to expand and function more efficiently. More than 10,000 valves have been implanted globally. Three randomized controlled trials (STELVIO, BeLieVeR-HIFi, and VENT), have demonstrated the effectiveness of the Zephyr EBV in the improvement of patients’ lung function, exercise capacity, and quality of life.

According to the four European pulmonologists, two small long-term series have been published on the valves, which showed “a significant survival benefit in the successfully treated compared to the unsuccessfully treated group,” as the authors wrote in a press release.

Results from the first randomized, controlled STELVIO trial, which assessed Zephyr EBV therapy using the Chartis system to identify patients most likely to benefit from the procedure, were recently published in the New England Journal of Medicine. Results from another prospective study also showed that Zephyr EBV therapy benefits a broad range of patients with advanced-stage emphysema.

The Chartis System is a pulmonary diagnostic tool that allows physicians to identify which patients are appropriate for the Zephyr valve procedure.

In their report, the pulmonologists mention 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).” They also emphasized that valves remain “the only removable endoscopic lung volume reduction technique.”

The Zephyr EBV is currently approved for use in more than 30 countries outside the United States.

According to the press release, the expert panel included:

  • Prof. Felix Herth, M.D., Ph.D., FCCP, chairman and head of pneumology and respiratory care, Thoraxklinik, University of Heidelberg, Germany;
  • Klaus Rabe, M.D., Ph.D., professor of pulmonary medicine, University of Kiel and director of the Department of Pneumology, Clinic Grosshansdorf, in Ratzeburg, Germany;
  • Pallav Shah, M.D., MBBS, FRCP, consultant physician, The Royal Brompton Hospital and Chelsea & Westminster Hospital, London, England;
  • Dirk-Jan Slebos, M.D., Ph.D., Department of Pulmonary Diseases and the Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, The Netherlands.

The Zephyr EBV is currently approved for use in more than 30 countries outside the United States.

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