Long-Term Safety and Effectiveness of Bronchial Thermoplasty Demonstrated in Treating Severe Asthma
long-term safety of Boston Scientifics Alair® Bronchial Thermoplasty System
Natick, MA and Denver, CO (May 16, 2011) – Boston Scientific Corporation (NYSE: BSX) today announced long-term safety data from the Research in Severe Asthma (RISA) Trial, which demonstrated the maintenance of stable lung function and the absence of clinical complications over a five-year period in patients with severe refractory asthma treated with its Alair® Bronchial Thermoplasty System. The RISA Trial is the third in a series of clinical trials that have completed five years of follow-up for patients treated with bronchial thermoplasty (BT).
Results were presented at the annual meeting of the American Thoracic Society (ATS) in Denver by Ian Pavord, M.D., Professor of Medicine at the University of Leicester, UK and RISA Trial Principal Investigator.
With the addition of this new long-term data, I can confidently advise patients whose asthma is poorly controlled with medications that bronchial thermoplasty demonstrates a stable safety profile for at least five years, said Dr. Pavord. The Alair System offers a novel adjunctive therapy option, beyond use of inhaled corticosteroids and long-acting beta agonists, to provide long-term improvements in overall asthma control.
BT is a bronchoscopic procedure performed under moderate sedation on an outpatient basis. The Alair System delivers thermal energy to the airway wall in a precisely controlled manner to reduce excessive airway smooth muscle. It is designed to decrease the airways ability to constrict, thereby reducing asthma attack frequency and severity.
The presentation of five-year safety data from the RISA Trial follows two recently published peer-reviewed articles that further support positive long-term outcomes following bronchial thermoplasty:
- In February, the journal BMC Pulmonary Medicine published five-year safety data from the AIR Trial, a randomized controlled trial comparing BT to standard of care for patients with moderate to severe asthma. The publication highlighted the absence of clinical complications and the maintenance of stable lung function over a five-year period post-BT, supporting the long-term safety profile of BT.
- The current issue of Annals of Allergy Asthma & Immunology includes the article Persistence of Effectiveness of Bronchial Thermoplasty in Patients with Severe Asthma, which is available at www.annallergy.org. It presents findings from the pivotal Asthma Intervention Research 2 (AIR2) Trial that demonstrate the persistence of safety and effectiveness of BT at 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 Mario Castro, M.D., Professor of Medicine and Pediatrics at the Washington University School of Medicine, a Principal Investigator in the AIR2 Trial and lead author of the AIR2 paper. These clinically meaningful improvements, combined with consistent and stable long-term safety, confirm bronchial thermoplasty as an important new treatment option for patients with severe asthma that is poorly controlled with currently available medications.
In summary, bronchial thermoplasty has demonstrated a strong long-term safety profile with follow up out to five years in three consecutive clinical trials. In addition to safety, the two-year results from the AIR2 Trial also demonstrate long-term persistence of effect.
The Alair Bronchial Thermoplasty System, which provides long-lasting and improved asthma control for adult severe asthma patients whose asthma is not well controlled by current drugs (inhaled medications), has been developed by Asthmatx, which was acquired by Boston Scientific in 2010.
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 healthcare 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
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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