Seattle, WA - Uptake Medical Inc., the developer of the InterVapor® System for Bronchoscopic Thermal Vapor Ablation (BTVA®), today announced the enrollment of the first emphysema patients into the NEXT STEP feasibility study at the Thoraxklinik in Heidelberg, Germany.
The NEXT STEP study is designed to validate the safety and efficacy of treating a patient in the most diseased segment of the lung regardless of where it is located. The BTVA procedure is currently indicated for use in upper lobe emphysema.
“The majority of patients we see have diseased segments dispersed throughout the lung. BTVA is the first therapy to offer a tailored solution of only treating those most diseased segments. If the study is successful it has the potential to more optimally treat many emphysema sufferers.” said Professor Felix Herth, lead author of the study and chairman of the Department of Pneumology and Critical Care Medicine at Thoraxklinik University of Heidelberg, Germany.
Robert Barry, Founder and Inventor of the BTVA therapy stated that “The CT scan data for Gold stage III & IV patients indicates that most patients have emphysematous segments randomly distributed with healthier segments throughout the lung. These hyperinflated emphysematous segments not only have poor gas exchange, but also impinge upon healthier segments. Targeted precise segmental ablation reduces the volume and mass of these hyperinflated emphysematous segments. This allows the healthier segments to expand resulting in clinically meaningful improvement in pulmonary function and quality of life¹. This treatment concept has been proven in upper lobe segments by virtue of the successful completion of the STEP-UP multi-national randomized controlled trial. As the name implies, the “NEXT STEP” study takes the next step of applying this treatment concept to all lobes (the entire lung). If successful, most GOLD stage III & IV patients will be eligible for BTVA treatment.”
BTVA is a simple, quick, and non-invasive procedure that typically takes less than 15 minutes. The procedure can be performed under light sedation. A thin tube (bronchoscope) is navigated down the airway to the diseased areas of the lung. Then vapor is delivered through the tube to these diseased regions. The vapor ablates the diseased tissue and the body removes the ablated tissue through the natural healing process.
CAUTION: The BTVA InterVapor System is not approved for use in the United States.
For further information contact:
Broncus Medical, Inc./Uptake Medical Technology, Inc.
About Uptake Medical Inc.
Uptake Medical®, a Broncus Company, is a commercial-stage medical device company based in Seattle, WA, USA. Uptake Medical is dedicated to improving the lives of patients suffering from pulmonary disease with vapor ablation.
To learn more about Bronchoscopic Thermal Vapor Ablation (BTVA), please visit: www.uptakemedical.com
About Broncus Medical, Inc.
Broncus Medical, Inc. is dedicated to the development of diagnostic and therapeutic technology for lung disease. Founded in 2012, the company’s primary technology platforms focus on the diagnosis of lung cancer. Its lung cancer portfolio includes the Archimedes™ System, Archimedes™ Planner, LungPoint® Virtual Bronchoscopic Navigation (VBN) System, LungPoint® Planner and FleXNeedle®.
¹ Herth et a. Lancet Respir Med 2016, http://dx.doi.org/10.1016/S2213-2600(16)00045-X