Date: 2015-05-18
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the American Thoracic Society (ATS) Annual Meeting
Company: Pulmonx (Switzerland - USA - CA)
Product: Zephyr® Endobronchial Valve
Action
mechanism: The Zephyr® Endobronchial Valve (Zephyr EBV) is a minimally invasive treatment for severe emphysema that has been proven in over a decade of clinical experience to significantly improve the lung function, exercise tolerance and quality of life for patients receiving treatment. A proprietary diagnostic – the Chartis System – is utilized prior to the procedure to identify likely responders. In the procedure, tiny, one-way valves are placed in the lungs to block airflow to diseased regions to achieve lung volume reduction. As a result, the remaining healthy regions may function more efficiently, enabling better breathing and an improved quality of life. Zephyr EBVs have been implanted globally in more than 10,000 patients.
Disease: severe emphysema
Therapeutic area: Lung diseases - Respiratory diseases
Country:
Trial details:
Latest
news: * On May 18, 2015, Pulmonx®, a leader in interventional pulmonology, announced results from a retrospective analysis of the landmark VENT trial that demonstrated a statistically significant benefit in severe emphysema patients with homogeneous disease that received treatment with the Zephyr® Endobronchial Valve (EBV). The data was presented at the American Thoracic Society (ATS) Annual Meeting. The retrospective analysis of the VENT trial examined outcomes of Zephyr EBV treatment in 25 patients with homogeneous disease distribution, defined by heterogeneity scores of <15 percent between treated and adjacent lobes. At six months, FEV1 in the homogeneous cohort improved 16 percent, which was statistically significant compared to the baseline. The analysis showed that patients with homogeneous disease who have low collateral ventilation can benefit from endobronchial lung volume reduction. The findings were presented by Professor Felix Herth, MD, PhD, FCCP, Chairman and Head of Pneumology and Respiratory Care at Thoraxklinik, University of Heidelberg. As a result of the results seen in the VENT analysis, Pulmonx also announced active enrollment in the prospective, randomized, multi-center IMPACT study, the first study to examine the benefits of the Zephyr EBV exclusively in a homogeneous patient population. The study will enroll 56 patients to assess the clinical efficacy of the Zephyr EBV versus medical management. The IMPACT study leverages improved techniques not utilized in VENT for patient screening, selection and treatment, including using HRCT analysis and functional assessments of collateral ventilation using the Chartis system. Co-principal investigators for the IMPACT study are Associate Professor Arschang Valipour, MD, FCCP, of The Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology at Otto-Wagner-Spital in Vienna, Austria, and Professor Ralf Eberhardt, MD, of Thoraxklinik, University of Heidelberg. The IMPACT study is taking place at leading medical centers in Austria, Germany and the Netherlands. Results from the STELVIO trial were also presented at ATS and provided further support that, independent of heterogeneity or homogeneity, severe emphysema patients with low collateral ventilation experience statistically and clinically significant improvements in pulmonary function, exercise capacity and quality of life after treatment with the Zephyr EBV.
