SUNNYVALE, Calif., Nov. 9 Asthmatx, Inc. presented the results of a series of studies investigating the effectiveness and safety of bronchial thermoplasty delivered by the AlairŪ System, and how this new procedure will impact allergy practices, this past weekend in a poster at the 2009 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI), in Miami Beach, Fla.
The poster, titled "Where Could Bronchial Thermoplasty (BT) Fit Into Your Allergy Practice? Lessons Learned from Multiple Bronchial Thermoplasty Clinical Trials," highlighted the clinical results from three randomized clinical trials, which investigated bronchial thermoplasty's effectiveness as a treatment option for patients with severe asthma.
Bronchial thermoplasty is a non-drug procedure developed to treat adults with severe asthma and is designed to provide improved asthma quality of life and control that lasts for at least one year. Bronchial thermoplasty delivered by the Alair System uses thermal energy to reduce the amount of smooth muscle in the lungs, which is associated with airway constriction in asthma patients.
"We have now shown in numerous clinical trials that patients whose severe asthma is uncontrolled by standard medications can now experience clinically significant improvements in their asthma control and their quality of life following treatment with the Alair System," said Glen French, CEO of Asthmatx. "This poster demonstrates that allergists may soon have a new option to consider for their patients with severe asthma."
The poster noted that, while the risks of bronchial thermoplasty include transient worsening of asthma, patients on high doses of inhaled corticosteroids and long-acting bronchodilators with impaired quality of life experience meaningful improvements in their overall asthma status. The poster authors concluded that allergists should consider referring appropriate patients for bronchial thermoplasty when standard medications are not sufficient to control their severe asthma.
In the period immediately following bronchial thermoplasty, there is an expected transient increase in the frequency and worsening of respiratory-related symptoms, which are of the type expected following bronchoscopy in patients with asthma. These events typically occur within a day of the procedure and resolve on average within seven days with standard care. In the long term, fewer bronchial thermoplasty treated patients reported respiratory adverse events and there was a significant decrease in patients reporting asthma (multiple symptoms) adverse events in the Alair-treated group compared to the sham control group.
About Bronchial Thermoplasty Delivered by the Alair System
Bronchial thermoplasty is a non-drug procedure for asthma. The treatment is performed through the working channel of a standard flexible bronchoscope that is introduced through a patient's 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 minimally invasive procedure, like many other flexible endoscopy procedures, is done under light anesthesia, and the patient returns home the same day.
In October 2009, 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 AlairŪ 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.
CAUTION: The Alair System is an Investigational Device. It is limited by United States law to investigational use. To be used by Qualified Investigators only.
Asthmatx is developing catheter-based medical devices for the treatment of asthma. Asthmatx has developed the Alair System to perform an investigational outpatient procedure called bronchial thermoplasty. The Alair System has received a CE Mark for use in the European Union. For more information on Asthmatx visit www.asthmatx.com.
Alair, Asthmatx and the Asthmatx logo are registered trademarks of Asthmatx, Inc.
SOURCE Asthmatx, Inc.