, Nov. 2, 2010
/PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that its newly acquired subsidiary, Asthmatx, Inc., presented two-year results from the Asthma Intervention Research 2 (AIR2) Trial demonstrating the long-term safety and effectiveness of bronchial thermoplasty (BT) in adult patients with severe asthma. Results were presented by Mario Castro
, M.D., Professor of Medicine and Pediatrics, Washington University
School of Medicine and Principal Investigator of the AIR2 Trial, at the CHEST 2010 meeting of the American College of Chest Physicians in Vancouver
Two-year results from the AIR2 Trial highlighted key long-term findings demonstrating the persistence of safety and effectiveness of bronchial thermoplasty based on the proportion of patients experiencing severe exacerbations in year two compared to year one. The 32 percent reduction in severe exacerbations and 84 percent reduction in emergency room visits for respiratory symptoms observed at one year in patients treated with BT compared to a control group that received a sham procedure remained comparable out to two years.
"It is rewarding to see the important benefits of bronchial thermoplasty persist out to two years in patients with severe asthma studied in the AIR2 Trial," said Dr. Castro. "The clinically meaningful improvements, combined with the consistent and stable long-term safety, confirm bronchial thermoplasty as an important new treatment option for patients with severe asthma who are poorly controlled despite using high-dose inhaled corticosteroids and long-acting bronchodilators."
Bronchial thermoplasty is a bronchoscopic procedure routinely performed under moderate sedation with patients typically returning home the same day. The Alair® System delivers precisely controlled thermal energy to the airway wall to reduce excessive airway smooth muscle. The procedure decreases the ability of the airways to constrict, thereby reducing the frequency and severity of asthma attacks.
The AIR2 Trial is a multi-center, randomized, sham-controlled clinical study designed to demonstrate the safety and effectiveness of bronchial thermoplasty in adult patients with severe asthma that remains poorly controlled despite treatment with standard asthma medications. Positive safety and effectiveness data at one year post-bronchial thermoplasty were published in the January 2010 issue of the American Journal of Respiratory and Critical Care Medicine.
During the period immediately following bronchial thermoplasty in the AIR2 Trial, there was an expected transient increase in the frequency and worsening of respiratory-related symptoms, which were of the type expected following bronchoscopy in patients with asthma. These events typically occurred within a day of the procedure and resolved on average within seven days with standard care.
Asthma is one of the most common and costly diseases in the world. The prevalence of asthma has grown in recent decades, and there is no cure. According to the Asthma and Allergy Foundation of America, more than 20 million Americans have asthma. Managing asthma consumes more than $18 billion of health care resources each year in the U.S. Uncontrolled asthma results in approximately 10 million unscheduled physician office visits, 2 million emergency rooms visits, 500,000 hospitalizations, and 4,000 deaths annually in the U.S. Five to 10 percent of those suffering from asthma in the U.S. are diagnosed with severe persistent asthma.
Asthmatx, Inc., a Boston Scientific Company, is focused on helping patients breathe easier. Asthmatx has developed a catheter-based outpatient procedure that provides long-lasting and improved asthma control for adult severe asthma patients. For more information, please visit www.BTforAsthma.com or www.bronchialthermoplasty.com.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
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