New bronchial thermoplasty long-term safety data in asthma presented at ATS annual meeting

Boston Scientific CorporationMay 17 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 airway's 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."