April 29, 2010 -- The FDA has approved the first non-drug, device-based treatment for adults with severe asthma whose medications aren't providing enough relief.
The device, called an Alair Bronchial Thermoplasty System, uses a catheter with a tip that delivers a form of thermal energy to the airways, the FDA says in a news release.
The FDA says the procedure is aimed at helping people ages 18 and older whose severe, persistent asthma is not controlled well enough with inhaled corticosteroids and long-acting beta-agonist medications.
The catheter delivers radiofrequency energy directly to the airways, heating lung tissue and reducing the thickness of smooth muscle, thus improving the ability of asthmatics to breathe.
"The approval of the Alair system provides adult patients suffering from severe and persistent asthma with an additional treatment option for a disease that is often difficult to manage," says Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health.
Approval of the procedure was based on data from a clinical trial of 297 patients who suffer from severe and persistent asthma. The trial showed a reduction of severe asthma attacks with use of the Alair system, the FDA says.
The agency says it is requiring a five-year study of the device to determine its long-term safety and effectiveness.
Asthmatx Inc., the Sunnyvale, Calif.-based manufacturer, will follow many of the patients who took part in the clinical trial and enroll 300 new patients at several medical centers across the country, the FDA says.
The Alair system, the FDA says, is designed to reduce the number of severe asthma attacks over the long term and is not for use in patients with implantable devices such as pacemakers or internal defibrillators.
Patients known to be sensitive to lidocaine, atropine, or benzodiazepines also shouldn't use the device, the FDA says.
The agency says asthma patients considering use of the Alair system should not be treated while experiencing an active respiratory infection, a bleeding disorder, asthma exacerbations, or if they've had changes to their corticosteroid regimen in the past two weeks.