09:10 uur 10-03-2016

Longexperts bevelen endobronchiale klep Zephyr van Pulmonx aan als enige minimaal invasieve behandeling van emfyseem voor gebruik buiten klinisch onderzoek

REDWOOD CITY, Calif.–(BUSINESS WIRE)—Pulmonx, leider in interventionele longgeneeskunde, heeft vandaag de publicatie van een aanbeveling door een expertisepanel in Respiration aangekondigd, waarin staat dat de minimaal invasieve endobronchiale klep van het het bedrijf, de Zephyr, en invasieve operaties ter vermindering van het longvolume ‘een bewijsniveau hebben bereikt voor gebruik buiten klinische proeven’ ten behoeve van behandelingen van een ernstig emfyseem. De bevindingen van het panel zijn gebaseerd op een systematische beoordeling en meta-analyse van klinisch bewijs dat tot op heden voorhanden is voor zes verschillende therapieën: een operatie ter vermindering van het longvolume, een endobronchiale klep, spiraaltjes, intrabronchiale kleppen, verwijdering door thermale damp (stomen) en biologische reductie van het longvolume.

Pulmonary Experts Recommend Zephyr Endobronchial Valve (EBV) from Pulmonx as Only Minimally-Invasive Emphysema Treatment to Be Used Outside Clinical Trials

 

REDWOOD CITY, Calif.–(BUSINESS WIRE)– Pulmonx®, a leader in interventional pulmonology, today announced publication of an expert panel recommendation in Respiration which concluded that only the company’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. Their findings were based on a systematic review and meta-analysis of clinical evidence to date for six different therapies: lung volume reduction surgery (LVRS), EBV, coils, intra bronchial valves (IBV), thermal vapor ablation (steam) and biological lung volume reduction.

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The Zephyr Endobronchial Valve (Photo: Business Wire)

The expert panel of pulmonologists were:

  • Professor Felix Herth, MD, PhD, FCCP, Chairman and Head of Pneumology and Respiratory Care, Thoraxklinik, University of Heidelberg, Heidelberg, Germany
  • Klaus Rabe , MD, PhD, Professor of Pulmonary Medicine, University of Kiel and Director of the Department of Pneumology, Clinic Grosshansdorf, Ratzeburg, Germany
  • Pallav Shah, MD, MBBS, FRCP, Consultant Physician, The Royal Brompton Hospital and Chelsea & Westminster Hospital, London, UK
  • Dirk-Jan Slebos, MD, PhD, Department of Pulmonary Diseases and the Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, Groningen, The Netherlands

The Zephyr EBV is the best studied of these options to-date, with three completed randomized controlled trials – STELVIO 1, BeLieVeR-HIFi 2 and VENT 3,4. 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 1,2,3,4. 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.”

The STELVIO trial, recently published in the New England Journal of Medicine, was the first randomized, controlled trial of Zephyr EBV therapy that used the Chartis® System to identify patients most likely to benefit. It also demonstrated in a prospective trial that Zephyr EBV therapy benefits a broad range of advanced stage emphysema patients, including those with heterogeneous disease and those with homogeneous disease 1.

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.”

The 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. The Chartis System is a proprietary diagnostic 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. Zephyr EBVs have been implanted globally in more than 10,000 patients. To view a video of the Zephyr EBV procedure, click here.

The Zephyr EBV is approved in over thirty countries outside the United States. For more information on patient eligibility and local hospitals offering the procedure, visitwww.pulmonx.com.

About Pulmonx

Based in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx is an interventional pulmonology company focused on developing life-changing, cost-effective technologies that improve the lives of patients suffering from lung disease worldwide. For more information, visit www.pulmonx.com.

  1. 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.
  2. 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; 386:1066–73; [Epub ahead of print: http://dx.doi.org/10.1016/S0140-6736(15)60001-0 (including supplementary appendix)].
  3. Sciurba FC, Ernst A, Herth FJF, Strange C, Criner G, Marquette C, et al. A Randomized Study of Endobronchial Valves for Advanced Emphysema. N Engl J Med 2010; 363: 1233-1244 (including supplementary appendix).
  4. Herth F, Noppen M, Valipour A, Leroy S, Vergnon J-M, Ficker JH, Egan E, Gasparini S, Agusti C, Homes-Higgin D, Ernst A on behalf of the International VENT Study Group. Efficacy predictors of endoscopic lung volume reduction with Zephyr valves in a European cohort with emphysema. Eur Respir J 2012; 39: 1334-1342.

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Chronic Communications
Michelle McAdam
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michelle@chronic-comm.com

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