Clinical Data Demonstrates Long Term Safety of Boston Scientific’s Alair[TM]Bronchial Thermoplasty System

Boston Scientific Corporation has announced 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 at the annual European Respiratory Society (ERS) Congress[1] in Amsterdam by Michel Laviolette, M.D., Professor of Medicine, Institut universitaire de cardiologie et de pneumologie at Université Laval in Québec City, Canada.

“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 System delivers 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.

Source: Boston Scientific

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