LONDON, January 26, 2012 /PRNewswire/ --

NICE Report Supports Safety and Effectiveness of Alair^® System

Boston Scientific (UK) welcomes new guidance from the National Institute for Health and Clinical Excellence (NICE) on the use of Bronchial Thermoplasty (BT) to treat adult patients with severe asthma that is not well controlled with medications.

The guidance, issued by the Institute's Interventional Procedures Advisory Committee (IPAC) states that "Evidence on the efficacy of bronchial thermoplasty for severe asthma shows some improvement in symptoms and quality of life, and a reduction in exacerbations and admission to hospital. Evidence on safety is adequate in the short and medium term."

"It is rewarding to receive positive guidance from NICE showing that BT is a safe and effective treatment option for severe asthma sufferers," said Tim Coutts, Vice President, General Manager UK, Nordic Countries and South Africa at Boston Scientific.  "The Alair^[TM] System has been well received in the UK and other countries where it has gained increased acceptance among physicians and patients.  This technology demonstrates Boston Scientific's commitment to improving patient quality of life through continuous innovation in minimally invasive medicine."

Bronchial Thermoplasty is a procedure performed under moderate sedation designed to help control severe asthma by reducing the mass of Airway Smooth Muscle (ASM). The Alair^[TM] Bronchial Thermoplasty System delivers thermal energy to the airway wall, heating the tissue in a controlled manner in order to reduce ASM mass. The procedure is designed to decrease the ability of the airway to constrict, thereby reducing asthma attack frequency and severity for patients with severe persistent asthma that is not well controlled with medications. BT has been demonstrated in published studies to reduce the number of severe exacerbations and hospital visits, as well as reduce time lost from work, school and other daily activities due to asthmatic symptoms.

The Alair Bronchial Thermoplasty System has been available in the UK since June 2011 and in other European countries since September 2011.  

In 2011, Boston Scientific announced long-term clinical data from the Research in Severe Asthma (RISA) Trial, demonstrating 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 the Alair Bronchial Thermoplasty System.

About Asthma

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.  

About NICE

The National Institute for Health and Clinical Excellence (NICE) is an independent, evidence-based organisation that provides recommendations on the use of new and existing medicines and treatments. NICE interventional procedures guidance, developed by an independent committee (IPAC) made up of 25 members with a range of expertise, advises the National Health Service (NHS) on the safety and efficacy of new interventional procedures.

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: http://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 our business plans, product performance and clinical trials.  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.

 

SOURCE Boston Scientific UK