The FDA has just issued a Breakthrough Device designation and an Investigational Device Exemption (IDE) to CSA Medical for its RejuvenAir system as a treatment option for patients with moderate to severe chronic obstructive pulmonary disease (COPD) that have chronic bronchitis. The company soon plans to start a prospective, multi-center, blinded randomized sham controlled trial, under the IDE, to evaluate the effectivness of the RejuvenAir system.
The system features a metered cryospray that delivers liquid nitrogen at -320° Fahrenheit (-196° Celsius) to specific targeted spots within the lungs. It sprays in a circular pattern, freezing the epithelial layer within the airway, hopefully destroying the goblet cells that produce mucus. Since the extracellular matrix is expected to be preserved after freezing, living cells can repopulate the treated area quickly.
“We are especially encouraged that the FDA approved the IDE unconditionally,” said Wendelin Maners, CSA Medical’s President in a published statement. “The study approval and device designation will allow us to greatly impact the lives of Chronic Bronchitis patients worldwide and collect significant clinical data surrounding our novel system.”