The U.K.’s National Institute for Health & Care Excellence updated its guidance for the valves, saying it considers the clinical evidence behind them sufficient to support routine use. The one-way valves, Pulmonx’s Zephyr and the Spiration device made by Olympus, are designed to partition diseased lung tissue from healthy tissue to improve respiratory efficiency.
Redwood City, Calif.-based Pulmonx said the decision was based on data from a quartet of studies of its Zephyr EBV, which is approved in Europe and Australia. The NICE noted that, “Different studies used different types of endobronchial valves. Most of the evidence comes from one of the valves (Zephyr, Pulmonx). The devices do not seem to be equivalent in safety and efficacy.”
Pulmonx said it’s won support from the relevant agencies in Germany, Switzerland and Holland.
“These decisions will increase patient access to our proven and minimally-invasive Zephyr technology, which has the potential to significantly improve the quality of life for patients,” CEO Glen French said in prepared remarks.
“In light of the high burden of symptoms, progressive nature of emphysema and poor prognosis for patients, the NICE decision means that patients with severe emphysema should be referred to specialists to determine if they are good candidates for endobronchial valves or other interventions,” added Dr. Pallav Shah of London’s Royal Brompton and Chelsea & Westminster Hospitals.