REDWOOD CITY, Calif. – December 20, 2017 – Pulmonx® Corp. today announced that the UK's National Institute for Health and Care Excellence (NICE) has updated its guidance for endobronchial valves used to treat severe emphysema, an advanced form of chronic obstructive pulmonary disease (COPD), and now considers current evidence sufficient to support routine use.
The change in NICE guidance is based on safety and efficacy data from multiple randomized clinical trials evaluating Zephyr® Endobronchial Valves (EBV®), which have demonstrated benefits for patients in quality of life, exercise capacity and lung function, as well as long-term safety. In fact, four randomized controlled trials of the Zephyr EBV (BeLieVeR-HiFI, TRANSFORM, STELVIO and IMPACT) provide a significant body of evidence supporting the ability of the treatment to significantly improve lung function, exercise tolerance and quality of life in emphysema patients with no collateral ventilation, as assessed with the Chartis System.1,2,3,4
"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," said Pallav Shah, MD, consultant physician in respiratory medicine at Royal Brompton Hospital and Chelsea & Westminster Hospital, London.
The British Lung Foundation estimates that in the UK, 1.2 million people are living with diagnosed COPD and almost 30,000 die from the disease every year.5 Roughly one-third of COPD patients have a form of the disease called emphysema.6 Emphysema causes damage to the alveoli, the air sacs in the lungs, which allows air to escape and prevents patients from taking in full breaths. This chronic breathlessness makes even the simplest daily activities difficult, such as washing, eating, walking and household chores, and often leads to patients becoming housebound and depressed. In fact, the quality of life for emphysema patients is worse than that for lung cancer.7
Zephyr EBVs are tiny, minimally-invasive, one-way valves placed via a flexible bronchoscope in airways in the lungs to occlude diseased regions and reduce lung hyperinflation. As a result, the remaining healthier regions can function more efficiently, enabling better breathing and an improved quality of life for patients.
Zephyr EBVs are routinely used in Europe and Australia as a treatment for severe emphysema. The treatment has been included in influential international guidelines from such groups as the Global Initiative for Chronic Obstructive Lung Disease (GOLD).8 The well-known independent Cochrane Airways Group also published a review of the available evidence earlier this year and concluded that, with proper patient selection, bronchoscopic lung volume reduction techniques – such as the Zephyr EBV – should be considered for severe emphysema patients when medical therapy has failed.9
Germany and Switzerland have supported EBV use in eligible patients for several years, and late last month, the Dutch organization for reimbursement – the Zorginstituut Nederland – ruled that EBVs are considered an effective treatment in adult patients with severe emphysema and will now be covered by the government.10
"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," said Pulmonx CEO Glen French.
Over the past 10 years, more than 50,000 Zephyr EBVs have been implanted globally in more than 12,000 patients. To view a video of the Zephyr EBV procedure, click here.
The Zephyr EBVSystem is an investigational device in the United States. Limited by U.S. law to investigational use only.
- Klooster K, Ten Hacken NHT, Hartman JE, Kerstjens HAM, Van Rikxoort EM, Slebos DJ. Endobronchial valves for emphysema without interlobar collateral ventilation. N Engl J Med 2015; 373:2325-2335.
- Davey C, Zoumot Z, Jordan S, McNulty W, Carr D, Hind M, et al. Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial. Lancet 2015;386(9998):1066-73.
- Kemp SV, et al. A multicenter RCT of Zephyr Endobronchial Valve treatment in heterogeneous emphysema (TRANSFORM). Am J Respir Crit Care Med 2017;https://doi.org/10.1164/rccm.201707-1327OC
- Valipour A, et al. Endobronchial valve therapy in patients with homogeneous emphysema. Results from the IMPACT study. Am J Respir Crit Care Med 2016;194(9):1073-1082.
- Gore JM, Brophy CJ, Greenstone MA. How well do we care for patients with end stage chronic obstructive pulmonary disease (COPD)? A comparison of palliative care and quality of life in COPD and lung cancer. Thorax 2000;55(12):1000-1006.
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