NATICK, Mass., March 27, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces the first published technology assessment in support of the safety, efficacy and long-term positive health outcomes of bronchial thermoplasty (BT) as delivered by the Alair® Bronchial Thermoplasty System, a catheter-based device designed to treat patients 18 years or older with severe persistent asthma. The report was published by the California Technology Assessment Forum (CTAF) and states that BT, when performed in patients with poorly controlled severe persistent asthma, meets its five technology assessment criteria.
"The American Thoracic Society believes bronchial thermoplasty meets all five of CTAF's technology assessment criteria," stated Stephen Hoffmann, M.D., chair of the American Thoracic Society Clinical Practice Committee, during the CTAF panel consideration of bronchial thermoplasty held in October 2011. "Our society believes the available data demonstrate that bronchial thermoplasty is safe and effective and improves net health outcomes for a well-defined patient population."
CTAF members concluded that BT meets the following assessment criteria: 1) BT has final approval from the appropriate government regulatory bodies (in this case the U.S. Food and Drug Administration (FDA)); 2) the scientific evidence for BT permits conclusions concerning the effectiveness of the technology regarding health outcomes; 3) BT improves net health outcomes; 4) BT is as beneficial as any established alternatives; and 5) the improvement associated with BT is attainable outside of investigational settings. CTAF recently posted its positive technology assessment of BT on its web site (www.ctaf.org) on March 23, 2012.
"I am pleased with the CTAF technology assessment report on bronchial thermoplasty, which is supported by the published literature showing BT results in positive net health outcomes for patients with severe persistent asthma. The AIR2 Trial showed superiority of BT compared to a sham control, and its extension study indicated a persistence of benefit out to at least two years," 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. "Patients with severe persistent asthma that is not well controlled with medication experience a very poor quality of life and suffer from exacerbations of their asthma at unexpected times. BT is an option for these patients, providing true long-term asthma control."
CTAF, an influential technology assessment organization for more than 50 years, identifies medical technologies supported by scientific evidence that improve health. Its purpose is to bring objectivity and transparency regarding new technologies to the U.S health care delivery system. CTAF technology assessment reviews are managed by the Blue Shield of California Foundation. CTAF's five assessment criteria are similar to those highlighted by the Blue Cross Blue Shield Technology Evaluation Center, a leading technology assessment body that is often referenced by payers in their coverage policies.
"It is rewarding to see the important benefits of bronchial thermoplasty recognized by a leading technology assessment organization like CTAF," said Parashar Patel, Vice President, Global Health Economics and Reimbursement for Boston Scientific. "We are gratified that scientific health outcomes evaluators confirm bronchial thermoplasty as an important new treatment option for patients with severe asthma that is poorly controlled with currently available medications."
Bronchial thermoplasty is a bronchoscopic procedure performed under moderate sedation on an outpatient basis. BT is performed with the Alair® Bronchial Thermoplasty System, an FDA-approved and CE Marked device that 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 for patients with severe persistent asthma that is not well controlled with inhaled corticosteroids and long-acting beta-agonists.
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 that are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
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SOURCE Boston Scientific Corporation