Thermoplasty device for asthma.
The FDA approved a thermal device that ablates airway smooth muscle to treat severe, persistent asthma that is not well controlled with medication.
The device uses a radiofrequency (RF) generator and a single-use catheter with an electrode basket at the tip to deliver RF energy to the airway wall to reduce smooth muscle. The procedure is performed as outpatient bronchoscopy.
Asthmatx Inc. will market the device as the Alair Bronchial Thermoplasty System. The thermoplasty system is the first medical device to use RF energy to treat severe and persistent asthma "'in certain adults," according to the FDA statement announcing the approval. The RF energy "heats the lung tissue in a controlled manner, reducing the thickness of smooth muscle in the airways and improving a patient's ability to breathe," the FDA statement noted, adding that multiple treatment sessions to target different parts of the lungs are required for patients to benefit from treatment.
The FDA based its approval decision on a randomized, double-blind, controlled trial of 297 patients with severe, persistent asthma who experienced symptoms despite treatment with inhaled corticosteroids and long-acting beta agonists (Am. J. Respir. Crit. Care Med. 2010;181:116-24). In that study, patients treated with the Alair system had improvements in asthma-specific quality of life and a reduction in severe exacerbations, as well as improvements in asthma-related quality of life.
--From staff reports
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|Title Annotation:||NEWS FROM THE FDA|
|Publication:||Family Practice News|
|Article Type:||Brief article|
|Date:||Jun 1, 2010|
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