Bronchial Thermoplasty with Boston Scientific’s Alair® System Meets All Criteria of California Technology Assessment Forum
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.
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 technology assessment reports, clinical trials, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, 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.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
CONTACT: Eric Olson 336-293-4393 (office) Media Relations Boston Scientific Corporation email@example.com Sean Findlen 617-520-7268 (office) Media Relations Weber Shandwick firstname.lastname@example.org Sean Wirtjes 508-652-5305 (office) Investor Relations Boston Scientific Corporation email@example.com
SOURCE Boston Scientific Corporation