Boston Scientific Corporation (NYSE: BSX) 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.
About Asthma
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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding new product launches and launch cadence, regulatory approvals, clinical trials, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
Source: Boston Scientific Corporation