National Institute for Health and Care Excellence Provides Positive Guidance for Use of Boston Scientific GreenLight XPS™ Laser Therapy System in the Treatment of BPH

MARLBOROUGH, Mass., June 14, 2016 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced that its GreenLight XPS™ Laser Therapy System, used for the treatment of prostatic enlargement, known as benign prostatic hyperplasia (BPH), received positive guidance from the National Institute for Health and Care Excellence (NICE). NICE provides evidenced-based guidance, advice and standards for the National Health Service (NHS) in England in order to improve outcomes for patients.

In its evaluation, NICE concluded that the adoption of the GreenLight XPS Laser Therapy System to treat non high-risk patients with BPH can significantly reduce costs for the NHS. NICE estimates that broad adoption of the GreenLight XPS Laser System over the current traditional surgical treatment, transurethral resection of the prostate (TURP), could result in savings of around £2.3 million and possibly up to £3.2 million annually for the NHS as the GreenLight XPS System therapy is typically done on an outpatient day-case basis. The British Association for Day Case Surgery (BADS 2013) has recommended that within the next five years, more than 90 percent of urological surgery should be done as day-case procedures. 

"The GreenLight XPS System is a well-established treatment to help men with BPH," said Mr. Gordon Muir, consultant urological surgeon, King's College Hospital, London, England. "It is suitable for almost all men, even those who may not be deemed fit for conventional surgery. The positive guidance from NICE will give more men access to the GreenLight XPS System and may allow surgeons to treat patients on an outpatient basis, with excellent outcomes and with fewer complications."

The NICE evaluation team examined information submitted by the company along with independently sourced clinical studies including the GOLIATH study, a randomized prospective trial of 291 patients conducted in nine European countries that compared the GreenLight XPS System to TURP. This study demonstrated that the laser therapy has fewer initial serious post-procedure complications, with lower hospital re-admissions and outcomes that are equally effective as the current standard surgical treatment ^1,2.

"Using technology to improve care and lower health care costs directly benefits patients, hospitals and providers," said Michael Phalen, executive vice president and president, MedSurg, Boston Scientific. "NICE is internationally recognized for its evidence-based review process and this guidance demonstrates the importance of continually evaluating how we can make improvements in caring for patients."

More than 110 million men worldwide are diagnosed with BPH, an enlargement of the prostate that occurs naturally with age and is one of the most common diseases among aging men³. It affects 50 percent of men between the ages of 51 and 60 and 90 percent of men over the age of 80⁴. BPH causes a number of symptoms and, if untreated, can result in infections, renal failure and kidney stones^4,5. A variety of treatment options are used to treat BPH including medication, surgery and laser therapy.

For more product and important safety information, please visit the GreenLight XPS System site. Or follow Boston Scientific Urology on Twitter at @bsc_urology.

Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

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 guidance from NICE and product performance and impact. 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.

1.     Data from initial 6 month endpoint of GOLIATH study, XPS results in a lower rate of early reinterventions but has a similar rate after 6 months. Bachmann A, et al. "180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study." European Urology 65.5 (2014): 931-42. Web.

2.     Jovanovic, M., Zoran Dzamic, Miodrag Acimovic, Boris Kajmakovic, and Tomislav Pejcic. "Usage of GreenLight HPS 180-W Laser Vaporisation for Treatment of Benign Prostatic Hyperplasia." ACTA CHIR IUG Acta Chirurgica Iugoslavica Acta Chir Iugo ACTA CHIR IUGOSL 61.1 (2014): 57-61. Web.

3.     "Prostate Enlargement: Benign Prostatic Hyperplasia." Prostate Enlargement: Benign Prostatic Hyperplasia. National Institute of Diabetes and Digestive and Kidney Diseases, 1 Sept. 2014. Web. 10 June 2016.

4.     Barry, Md M., and Md C. Roehrborn. "Management of Benign Prostatic Hyperplasia." Annual Review of Medicine Annu. Rev. Med. 48.1 (1997): 177-89. Print.

5.     Benign enlargement of prostate. ADAM Health Illustrated Encyclopedia. http://www.healthline.com/adamcontent/enlarged-prostate. Accessed Oct. 21, 2010.

6.     NICE guidance, 'GreenLight XPS for treating benign prostatic hyperplasia', www.nice.org.uk/mtg29.

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SOURCE Boston Scientific Corporation

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