Published on October 29, 2009 at 4:14 AM
Asthmatx Inc., announced today that the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to the U.S. Food and Drug Administration (FDA) voted to recommend that the Alair® System, a device utilized in bronchial thermoplasty for the treatment of severe persistent asthma in patients 18 years and older, be found approvable with conditions.
The Anesthesiology and Respiratory Therapy Devices Panel voted 6 to 1 in favor of approvable with conditions, which were primarily related to labeling and post-approval studies. The final decision regarding the approval of the device is made by the FDA and while the FDA is not required to follow the advice of its advisory committee, it generally does.
"The Advisory Panel's recommendation for approvable with conditions of the Alair System marks a major step in bringing this new and important treatment option to patients with severe asthma," said Glen French, CEO of Asthmatx. "We look forward to working with FDA through the next steps to product approval."
SOURCE Asthmatx Inc.