Broncus Technologies Inc, Mountain View, Calif, has announced the results of its open-label Exhale® drug-eluting stent feasibility study for the treatment of emphysema.
Positive results include a statistically significant reduction in the amount of air trapped in the lungs and an improvement in breathing 6 months after the airway bypass procedure. The study, led by Paulo F.G. Cardoso, MD, PhD, Division of Thoracic Surgery, Santa Casa de Porto Alegre-Pavilhao Pereira Filho Hospital, Brazil, has been published in the October issue of the Journal of Thoracic and Cardiovascular Surgery.
Airway bypass is a catheter-based bronchoscopic procedure designed to reduce lung hyperinflation and improve breathlessness—the clinical hallmarks of emphysema/COPD—by making new pathways for trapped air to exit the lungs. During the minimally invasive procedure, new openings are created in the airway wall connecting the damaged lung tissue to the natural airway. The pathways’ openings are maintained by stents.
The trial exceeded a goal of a 300 mL reduction in residual lung volume (RV), producing a 400 mL improvement in RV over baseline at 6 months. Patients also showed improvement in the modified Medical Research Council Dyspnea Scale (mMRC), a breathlessness test, of -0.5 points.
The study also showed that patients with the most severe lung hyperinflation derived the greatest benefit from the bypass. Six months after the procedure showed a mean improvement in RV of 870mL.
Currently, Broncus is involved in pivotal EASE Trial, the company’s largest clinical study to date.
To read the Exhale® press release, click here.
To view an abstract of the study, click here.