由 Lynn Shapiro
, Writer | January 14, 2009
Asthmatx, Inc., a medical device company that has developed a catheter-based procedure for the treatment of severe asthma, said it has submitted its PMA application for the Alair Bronchial Thermoplasty System. In addition, the company said that FDA has granted expedited review status to the device.
The device uses a technology known as bronchial thermoplasty, the first non-drug treatment for asthma. The treatment is performed through the working channel of a standard flexible bronchoscope that is introduced through patients' nose or mouth, and into their lungs.
The tip of the small diameter Alair catheter is expanded to contact the walls of targeted airways. Controlled thermal energy is then delivered to the airway walls to reduce the presence of airway smooth muscle that narrows the airways in patients with asthma.
The procedure, like many other flexible endoscopy procedures, is done under light anesthesia, and patients return home the same day. In the period immediately following bronchial thermoplasty, there is an expected increase and worsening of respiratory-related symptoms, which are of the type expected following bronchoscopy in patients with asthma, and resolve within seven days with standard care, the company said.
Asthamtix's PMA submission is based on one-year data on 297 patients from the company's pivotal trial, the Asthma Intervention Research 2 (AIR2) Trial. The AIR2 Trial was a multi-center, randomized, double-blind, sham-controlled clinical trial testing bronchial thermoplasty's safety and efficacy. The primary effectiveness endpoint was the change from baseline in the Asthma Quality of Life Questionnaire (AQLQ) score. Safety was assessed by comparing the short and long-term safety profiles for both groups.
To date, more than 800 bronchial thermoplasty bronchoscopies with long-term follow up data are available. The earliest patients have been followed for five years post-treatment.
"Unfortunately, despite an array of generally effective medications, there are still many severe asthma patients who either do not respond adequately to drugs, do not have access to appropriate treatment, or simply choose not to take their medications," says Mario Castro, MD, professor of medicine and pediatrics, Washington University School of Medicine, St. Louis, MO, and a principal investigator in the AIR2 Trial. "There is a significant unmet medical need to improve the care for patients with severe asthma by better controlling their asthma symptoms," he says.