New England Journal of Medicine Publishes Groundbreaking Study Demonstrating Benefits of Pulmonx's Medical Device for Emphysema
Pulmonx Corporation , a leader in interventional pulmonology, announced online publication today of results from the independent, randomized, controlled STELVIO trial in the New England Journal of Medicine . The trial demonstrated statistically and clinically significant outcomes in lung function, exercise capacity and quality of life in severe emphysema patients identified with the Chartis® System , Pulmonx’s proprietary assessment system, and treated with the Zephyr® Endobronchial Valve (EBV), when compared to those receiving standard medical management.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20151209006607/en/
The STELVIO trial is the first randomized, controlled trial of Zephyr EBV therapy using the Chartis System to identify patients most likely to benefit. It is also the first prospective trial to demonstrate that Zephyr EBV therapy can benefit a broad range of advanced stage emphysema patients, including those with heterogeneous disease, where emphysema is isolated to specific areas of the lungs, and homogeneous disease, where emphysema is distributed evenly throughout the lungs. The trial was performed independently of Pulmonx.
In the STELVIO trial, 68 patients were confirmed with the Chartis System to be likely responders to Zephyr EBV therapy, and randomized to either EBV therapy or medical management. In patients who received EBV therapy, tiny one-way valves were placed in the lungs to block airflow to diseased regions with the goal of improving breathing.
At six months, compared to the medical management group, the EBV group had statistically and clinically greater improvements in pulmonary function (FEV1 change % predicted, EBV vs Control: 20.9% vs 3.1%; p=0.001), exercise capacity (6 Minute Walk Test, EBV vs Control: +19.6% vs -3.6%; p=0.001) and quality of life (SGRQ score, EBV vs Control: -21.8 vs -7.6; p=0.001). Also, a significantly greater number of patients in the EBV group responded to treatment. At the end of six months, control patients that crossed over to receive EBV therapy gained benefits similar to the original EBV-treated group.
The STELVIO trial was led by Karin Klooster and Dirk-Jan Slebos of the Department of Pulmonary Diseases and the Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, The Netherlands. The trial was funded by a Dutch government grant from ZonMW and the University Medical Center Groningen, The Netherlands.
“When we select patients with the Chartis System, endobronchial valve treatment provides improved lung function, exercise capacity, and quality of life,” said Karin Klooster, lead author of the publication. “When we identify the right patients for treatment, the improvements can be life-changing,“ said Principal Investigator Dr. Dirk-Jan Slebos.
“The STELVIO study provides independent confirmation that a broad range of patients with advanced emphysema have a high likelihood of achieving clinically meaningful benefits from Zephyr EBV therapy when a systematic approach is followed and careful patient selection is performed using the Chartis System,” said Pulmonx Chief Executive Officer Glen French .
The 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. 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 for patients who can then perform more activities of daily life. Zephyr EBVs have been implanted globally in more than 10,000 patients.
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 . To view a video of the Zephyr EBV procedure, click here .
The Zephyr® EBV is an investigational device in the United States. Limited by U.S. law to investigational use.
949-545-6654 or 310-902-1274
Information om Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco
Følg pressemeddelelser fra Business Wire
Skriv dig op her og modtag pressemeddelelser på mail. Indtast din mail, klik på abonner og følg instruktionerne i den udsendte mail.
Flere pressemeddelelser fra Business Wire
NJ-SYNCHRONOSS26.2.2018 00:21 | pressemeddelelse
Sprint Selects Synchronoss to Lead its Digital Transformation
HUAWEI25.2.2018 14:32 | pressemeddelelse
Huawei Brings the All-Connected World to Mobile World Congress
PATIENT-SAFETY-MOVEMENT24.2.2018 11:02 | pressemeddelelse
The 6th Annual World Patient Safety, Science & Technology Summit Kicked off with an Important Announcement about the Progress Being Made to Save Lives in Hospital Settings
CCWW24.2.2018 10:08 | pressemeddelelse
WuQi Technologies is Latest Licensee of CCww’s NB-IoT UE Protocol-Stack Software
IDEMIA23.2.2018 16:59 | pressemeddelelse
IDEMIA and Octo Telematics Reinvent Car Sharing Experience by Adding Facial Recognition to EasyOpen Solution
SM-OPTICS23.2.2018 15:02 | pressemeddelelse
SM-Optics Unveils First FLEXSET Chip, Paving the Way to Optical Micro Nodes
I vores nyhedsrum kan du læse alle vores pressemeddelelser, tilgå materiale i form af billeder og dokumenter, og finde vores kontaktoplysninger.Besøg vores nyhedsrum