FDA Advisory Panel Recommends Approval Of Bronchial Thermoplasty With Conditions
In a previous blog I discussed results from a trial of bronchial thermoplasty, a non-drug treatment where thermal energy is delivered to airways to reduce smooth muscle that narrows airways causing asthma symptoms.
Last week, the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to the U.S. Food and Drug Administration (FDA) recommended that the Alair® System, a device utilized in bronchial thermoplasty for the treatment of severe persistent asthma in patients 18 years and older, was approveable with certain conditions according to a company website.
Clinical trials have demonstrated:
- Significant improvement in quality of life
- 32 percent reduction in severe asthma attacks
- 84 percent reduction in emergency room visits for respiratory symptoms
- 66 percent reduction in days lost from work/school or other activities
"The Advisory Panel's recommendation for approvable with conditions of the Alair® System marks a major step in bringing this new and important treatment option to patients with severe asthma," said Glen French, CEO of Asthmatx in the press release. "We look forward to working with FDA through the next steps to product approval."
Pat, what does this mean? “”The Advisory Panel’s recommendation for approvable with conditions of the Alair® System”