Federal health advisers on Wednesday said a novel technology from a small medical technology firm should be approved as the first non-drug treatment for asthma.
The Food and Drug Administration's panel of respiratory device experts voted 6-1 that Asthmatx's Alair System be approved under certain conditions, including long-term safety monitoring of patients.
The FDA is not required to follow the group's advice, though it usually does.
The company's procedure, called bronchial thermoplasty, uses extreme heat to burn away lung tissue that makes it difficult to breath and causes coughing spasms and wheezing. The heat is delivered via a catheter that emits radiofrequency waves, similar to microwaves used to cook food. The procedure would be performed by respiratory specialists known as pulmonologists over the course of three, half-hour sessions.
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The Food and Drug Administration's panel of respiratory device experts voted 6-1 that Asthmatx's Alair System be approved under certain conditions, including long-term safety monitoring of patients.
The FDA is not required to follow the group's advice, though it usually does.
The company's procedure, called bronchial thermoplasty, uses extreme heat to burn away lung tissue that makes it difficult to breath and causes coughing spasms and wheezing. The heat is delivered via a catheter that emits radiofrequency waves, similar to microwaves used to cook food. The procedure would be performed by respiratory specialists known as pulmonologists over the course of three, half-hour sessions.
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