www.fdanews.com/articles/192600-gala-therapeutics-earns-ce-mark-for-chronic-bronchitis-treatment
Gala Therapeutics Earns CE Mark for Chronic Bronchitis Treatment
September 4, 2019
Gala Therapeutics’ RheOx system has received the CE Mark for treating patients with chronic bronchitis, a type of chronic obstructive pulmonary disease (COPD) in which the inflamed bronchial tubes create excessive mucus.
The device is used in a minimally invasive procedure called Bronchial Rheoplasty, in which it gives off non-thermal energy to the airways to reduce mucus-producing cells.
The company said it now plans to begin a postmarket study at key European respiratory centers to increase clinician experience with the procedure and device.