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”
It means that the FDA’s advisory panel has already approved the procedure. Everyone is just waiting on the FDA organization to approve it. Only waiting over a year.
Bronchial thermoplasty is a cure for asthma, unfortunately it is still sitting in the FDA in box. Call the FDA, call your congressman or senator, write your newspapers. ask them why it is still not approved. It was approved by their advisory committee back in Oct and by the European Union.
I can’t seem to locate any information in reguards to side effects of this procedure. My sister had the fist two thermoplastys and was doing great, but after the third on she had not been doing so well. We are now 4weeks out and she has been admitted to the hospital 3 times and now intubated and on a vent for the last 5days. Please help we are desperate to find out what is going on with her.