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Pulmonx Completes Enrollment of Randomized Multi-Center Study
Pulmonx Completes Enrollment of Randomized Multi-Center Study
IMPACT trial is the first to evaluate the benefits of Zephyr Endobronchial Valves for emphysema patients.
01.15.16
Pulmonx has finished enrolling patients in the IMPACT study, a prospective, randomized, multi-center trial that is the first to examine the benefits of the Zephyr Endobronchial Valve (EBV) specifically in patients with homogeneous emphysema.
The IMPACT study enrolled 93 patients with homogeneous severe emphysema to compare the safety and effectiveness of Zephyr EBV treatment versus medical management. The study is being led by Associate Professor Arschang Valipour, M.D., FCCP, of the Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology at Otto-Wagner-Spital in Vienna, Austria, and Professor Ralf Eberhardt, M.D., of Thoraxklinik, University of Heidelberg (co-principal investigators), and conducted at medical centers in Austria, Germany and the Netherlands.
It was previously thought that only patients with heterogeneous emphysema, where the disease is isolated to specific areas of the lungs, could benefit from lung volume reduction with endobronchial valves. The IMPACT study was launched based on the results of a retrospective analysis of the VENT trial, which indicated that patients with homogeneous disease, where emphysema is diffusely distributed, and little or no collateral ventilation can also benefit from endobronchial lung volume reduction with the Zephyr valve.1
The study uses the company’s proprietary Chartis System to select patients with little or no collateral ventilation, and advanced imaging technology to select a target lobe for treatment. The use of the Chartis System to select patients for EBV treatment was validated in the STELVIO trial, which was recently published in the New England Journal of Medicine.2 Results of the STELVIO trial showed that at six months, patients selected with the Chartis System and treated with the Zephyr EBV had statistically and clinically greater improvements in pulmonary function, exercise capacity and quality of life compared to patients managed medically. Importantly, STELVIO included patients with both heterogeneous and homogeneous emphysema, and both populations treated with the Zephyr EBV had statistically greater and clinically meaningful outcomes than medically managed patients.
“An ever-growing body of evidence supports the benefits of the Zephyr EBV in improving lung function and quality of life for patients,” said Valipour, co-principal investigator for the IMPACT study. “Retrospective studies have demonstrated the benefits of the EBV in patients with homogeneous emphysema. The IMPACT study is breaking new ground by prospectively evaluating the benefits of EBV treatment specifically in this homogeneous emphysema patient population, who clearly need additional treatment options.”
The Zephyr EBV is currently being studied in the United States as part of the pivotal LIBERATE trial. The Zephyr EBV is an investigational device in the United States.
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. More than 65 percent of severe emphysema patients have been shown to have low or no collateral ventilation in one or more target lobes of the lung, demonstrating a large potential market for the Zephyr EBV treatment. Zephyr EBVs have been implanted globally in more than 10,000 patients.
“Zephyr valves offer the greatest level of improvement of any minimally invasive procedure for emphysema, and valves are the only removable option,” said Pulmonx Chief Executive Officer Glen French. “Completing enrollment in the IMPACT study is an important milestone as we accumulate scientific evidence for the patient populations that can benefit the most from our treatment.”
Three randomized controlled trials of the Zephyr EBV (STELVIO, BeLieVeR-HIFi, VENT) conducted to date provide a significant body of evidence supporting the therapy. These and other 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 ventilation2,3,4,5.The clinical data also demonstrate sustained patient benefits out to five years.6
Based in Redwood City, Calif., and Neuchâtel, Switzerland, Pulmonx is an interventional pulmonology company focused on developing treatment technologies for lung disease.
References:
1. Herth FJ, Gompelmann D, Criner GJ, Sciurba FC, Ernst A, Eberhardt R. Lung Volume Reduction Using Endobronchial Valves in COPD Patients with Low Emphysema Heterogeneity Scores. Am J Respir Crit Care Med 191;2015: A1156.
2. 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.
3.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. The Lancet 2015; http://dx.doi.org/10.1016/S0140-6736(15)60001-0 (including supplementary appendix). [Epub ahead of print]
4. Sciurba FC, Ernst A, Herth FJF, Strange C, Criner G, Marquette C, et al. A Randomized Study of Endobronchial Valves for Advanced Emphysema. New Eng J Med 2010; 363: 1233-1244 (including supplementary appendix).
5. 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.
6. Venuta F, A Marco, D Daniele, Coloni, G, et. al. Long-term follow-up after bronchoscopic lung volume reduction in patients with emphysema. Eur Respir J 2012; 39: 1084–1089.
Watch a video of the Zephyr EBV procedure below:
The IMPACT study enrolled 93 patients with homogeneous severe emphysema to compare the safety and effectiveness of Zephyr EBV treatment versus medical management. The study is being led by Associate Professor Arschang Valipour, M.D., FCCP, of the Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology at Otto-Wagner-Spital in Vienna, Austria, and Professor Ralf Eberhardt, M.D., of Thoraxklinik, University of Heidelberg (co-principal investigators), and conducted at medical centers in Austria, Germany and the Netherlands.
It was previously thought that only patients with heterogeneous emphysema, where the disease is isolated to specific areas of the lungs, could benefit from lung volume reduction with endobronchial valves. The IMPACT study was launched based on the results of a retrospective analysis of the VENT trial, which indicated that patients with homogeneous disease, where emphysema is diffusely distributed, and little or no collateral ventilation can also benefit from endobronchial lung volume reduction with the Zephyr valve.1
The study uses the company’s proprietary Chartis System to select patients with little or no collateral ventilation, and advanced imaging technology to select a target lobe for treatment. The use of the Chartis System to select patients for EBV treatment was validated in the STELVIO trial, which was recently published in the New England Journal of Medicine.2 Results of the STELVIO trial showed that at six months, patients selected with the Chartis System and treated with the Zephyr EBV had statistically and clinically greater improvements in pulmonary function, exercise capacity and quality of life compared to patients managed medically. Importantly, STELVIO included patients with both heterogeneous and homogeneous emphysema, and both populations treated with the Zephyr EBV had statistically greater and clinically meaningful outcomes than medically managed patients.
“An ever-growing body of evidence supports the benefits of the Zephyr EBV in improving lung function and quality of life for patients,” said Valipour, co-principal investigator for the IMPACT study. “Retrospective studies have demonstrated the benefits of the EBV in patients with homogeneous emphysema. The IMPACT study is breaking new ground by prospectively evaluating the benefits of EBV treatment specifically in this homogeneous emphysema patient population, who clearly need additional treatment options.”
The Zephyr EBV is currently being studied in the United States as part of the pivotal LIBERATE trial. The Zephyr EBV is an investigational device in the United States.
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. More than 65 percent of severe emphysema patients have been shown to have low or no collateral ventilation in one or more target lobes of the lung, demonstrating a large potential market for the Zephyr EBV treatment. Zephyr EBVs have been implanted globally in more than 10,000 patients.
“Zephyr valves offer the greatest level of improvement of any minimally invasive procedure for emphysema, and valves are the only removable option,” said Pulmonx Chief Executive Officer Glen French. “Completing enrollment in the IMPACT study is an important milestone as we accumulate scientific evidence for the patient populations that can benefit the most from our treatment.”
Three randomized controlled trials of the Zephyr EBV (STELVIO, BeLieVeR-HIFi, VENT) conducted to date provide a significant body of evidence supporting the therapy. These and other 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 ventilation2,3,4,5.The clinical data also demonstrate sustained patient benefits out to five years.6
Based in Redwood City, Calif., and Neuchâtel, Switzerland, Pulmonx is an interventional pulmonology company focused on developing treatment technologies for lung disease.
References:
1. Herth FJ, Gompelmann D, Criner GJ, Sciurba FC, Ernst A, Eberhardt R. Lung Volume Reduction Using Endobronchial Valves in COPD Patients with Low Emphysema Heterogeneity Scores. Am J Respir Crit Care Med 191;2015: A1156.
2. 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.
3.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. The Lancet 2015; http://dx.doi.org/10.1016/S0140-6736(15)60001-0 (including supplementary appendix). [Epub ahead of print]
4. Sciurba FC, Ernst A, Herth FJF, Strange C, Criner G, Marquette C, et al. A Randomized Study of Endobronchial Valves for Advanced Emphysema. New Eng J Med 2010; 363: 1233-1244 (including supplementary appendix).
5. 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.
6. Venuta F, A Marco, D Daniele, Coloni, G, et. al. Long-term follow-up after bronchoscopic lung volume reduction in patients with emphysema. Eur Respir J 2012; 39: 1084–1089.
Watch a video of the Zephyr EBV procedure below:
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