Clinical Data Demonstrates Long-Term Safety of Boston Scientific’s Alair[TM]Bronchial Thermoplasty SystemBy Boston Scientific Corporation, PRNE
Monday, September 26, 2011
PARIS, September 27, 2011 -
- Five-year data from Research in Severe Asthma (RISA) Trial demonstrate maintenance of stable lung function and absence of late clinical complications
- Patients in Europe with severe asthma can now benefit from unique and proven non-drug therapy
Boston Scientific Corporation (NYSE: BSX) announces positive clinical data from the Research in Severe Asthma (RISA) Trial, demonstrating the long-term safety of bronchial thermoplasty (BT) in patients treated with the Company’s Alair™ Bronchial Thermoplasty System. Follow-up data demonstrate that stable lung function is maintained and late clinical complications are absent over a five-year period in patients with severe refractory asthma treated with BT. Results were presented today at the annual European Respiratory Society (ERS) Congress in Amsterdam by Michel Laviolette, M.D., Professor of Medicine, Institut universitaire de cardiologie et de pneumologie at Université Laval in Québec City, Canada.
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“Bronchial thermoplasty clinical data continue to support this promising therapy, which is creating real excitement in the physician community,” said Dr. Laviolette, a principal investigator for the RISA Trial. “Existing evidence suggests a significant long-term benefit, and results from the RISA Trial clearly confirm long-term safety. BT provides us a new option for treating patients with severe asthma that can provide proven reductions in hospital visits, out-of-pocket costs and missed workdays due to asthma symptoms.”
Long-term safety data from the RISA Trial are consistent with recently published five-year data from the Asthma Intervention Research (AIR) Trial, which also demonstrated a strong long-term safety profile for the Alair[TM] Bronchial Thermoplasty System. These data are also consistent with two-year results from the Asthma Intervention Research 2 (AIR2) Trial, which demonstrated safety and long-term persistence of effect. Clinical results from the AIR2 Trial at one year showed 32 percent reduction in asthma attacks, 84 percent reduction in emergency room visits for respiratory symptoms, 66 percent reduction in days lost from work, school or other daily activities due to asthma and improved asthma quality of life.
The Alair[TM] Bronchial Thermoplasty System has been available in the UK since June 2011 and in other European countries since September 2011. Initial BT cases were performed with positive results at Gartnavel General Hospital in Glasgow and Wythenshawe Hospital in Manchester. Most recently, physicians at Odense University Hospital in Denmark have performed initial BT procedures on severe asthma patients.
BT is a bronchoscopic procedure performed under moderate sedation. The Alair[TM] Bronchial Thermoplasty Systemdelivers thermal energy to the airway wall in a precise and controlled manner to reduce excessive airway smooth muscle. It is designed to decrease the ability of the airways to constrict, thereby reducing the frequency and severity of asthma attacks. Designed to complement conventional asthma drug treatments, clinical data show bronchial thermoplasty is safe and effective in the treatment of severe, persistent asthma in patients 18 years and older whose asthma is not well controlled with current medications.
Prof. Neil Thomson and Dr. Steve Bicknell at Gartnavel General Hospital were the first physicians in Europe to use BT treatment for severe asthma. Dr. Bicknell commented, “The availability of BT is a significant milestone for patients with severe, persistent asthma who often have poorly controlled symptoms and impaired quality of life despite current therapies. Bronchial thermoplasty offers a safe and effective device-based approach to the management of asthma.”
“Our acquisition of the Alair[TM] Bronchial Thermoplasty System, and its launch in Europe, demonstrate Boston Scientific’s commitment to improving patient quality of life through continuous innovation in minimally invasive medicine,” said Michael Onuscheck, Senior Vice President and President, Europe, Middle East and Africa at Boston Scientific. ”We are proud to offer this therapy option for severe asthma patients across Europe who cannot control their condition with drug therapy alone.”
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. Asthma affects approximately 30 million people in Europe and an estimated 300 million worldwide. Twenty percent of Europeans with severe persistent asthma cannot control their symptoms despite optimal drug therapy, leading to a high degree of morbidity and mortality. Patients with severe asthma often have significantly impaired quality of life, are frequently absent from school or work, have decreased productivity and are at increased risk of hospital admission and death. In 2002, asthma caused 12,000 deaths in Western Europe, and an estimated seven percent of Western Europeans with asthma are hospitalised due to asthma every year.
The Alair[TM] Bronchial Thermoplasty System, which is designed to provide long-lasting and improved asthma control for adult severe asthma patients whose asthma is not well controlled by current drugs (inhaled medications), was developed by Asthmatx, which was acquired by Boston Scientific in 2010.
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.
To view the latest webcast on the Alair[TM]Bronchial Thermoplasty System visit www.bscintlpresskit.com/alairwebcastERS
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 the market for pulmonary products, including the Alair[TM] Bronchial Thermoplasty System, and our position within that market, new product launches and launch cadence, regulatory approvals, clinical trials, product performance and acceptance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialise, 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.
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1. ERS abstract number 3930; presentation number 3422.
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