FDA OKs Device for Severe Adult Asthma

WASHINGTON, April 28 (UPI) — The U.S. Food and Drug Administration has approved the first device that uses radiofrequency energy to treat severe and persistent asthma in adults.

The FDA said the Alair Bronchial Thermoplasty System is intended for adults whose severe asthma is not well-controlled with inhaled corticosteroids and long-acting beta agonist medications.

Officials said the device uses a catheter with an electrode tip to deliver a form of electromagnetic energy, called radiofrequency energy, directly to the airways. A controller unit generates and controls the energy.

“Inflammation causes the airways of people who have asthma to swell and narrow, making breathing difficult,” the federal agency said in a statement. “The Alair system treats asthma symptoms by using radiofrequency energy to heat the lung tissue in a controlled manner, reducing the thickness of smooth muscle in the airways and improving a patient’s ability to breathe. To benefit, patients will require multiple sessions targeting different areas in the lungs.”

The Alair system is not for use in asthma patients with a pacemaker, internal defibrillator or other implantable electronic device, the FDA said, noting patients with known sensitivities to lidocaine, atropine or benzodiazepines should not use the device.

The system is manufactured by Asthmatx Inc. of Sunnyvale, Calif.

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