According to Dow Jones Newswires, an FDA panel has recommended the approval of Alair® bronchial thermoplasty device from Sunnyvale, California based Asthmatx, Inc. Designed to reduce the amount of smooth muscles in the walls of small to medium size airways, the device will likely be indicated for drug-resistant adult cases of severe asthma. We have reported extensively on this technology, including on positive results from the Asthma Intervention Research 2 (AIR2) Trial, a 300 patient strong study reported in May, that has showed reduction in extreme asthma attacks by 32 percent, and 84 percent reduction in emergency room trips in patients s/p treatment.
The device–the Alair Bronchial Thermoplasty System–if approved would be the first non-drug treatment approved by the FDA. The product is made by Asthmatx Inc., a closely held firm based in Sunnyvale, Calif., and is designed to be used in adult asthma patients whose disease isn’t well controlled on both short- and long-acting medications.
Specifically, the panel voted 6 to 1 that the treatment be approved with conditions, including a registry of patients treated to track the long-term safety and effectiveness of the device. The FDA typically follows the advice of its panels but isn’t required to. If approved, the device could be on the market during the first half of 2010.
The FDA noted that about 22 million Americans have asthma and about 4,000 people die each year "in spite of optimal medical management." About 500,000 people are hospitalized with asthma exacerbations annually in the U.S.
Dow Jones Newswires: FDA Panel Backs Novel Device To Treat Severe Asthma…
Technology page: Bronchial Thermoplasty…
Flashbacks: Bronchial Thermoplasty Does Well in AIR2 Trial ; The Alair® System for Bronchial Thermoplasty™; Alair System May Become Option for Asthmatics