Confirms clinical value and cost-effectiveness of spinal cord stimulation
NATICK, Mass., Oct. 27 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today welcomed an announcement by the U.K.'s National Institute for Health and Clinical Excellence (NICE) recommending the use of spinal cord stimulation (SCS) for patients with chronic neuropathic pain. In its comprehensive final guidance, NICE confirmed that SCS is both safe and clinically effective in these patients. Importantly, NICE also concluded that SCS is cost-effective when used to treat patients with chronic neuropathic pain, despite the use of conservative modeling techniques in the appraisal.
"This is a very positive decision for National Health Service (NHS) patients suffering from chronic neuropathic pain," said Dr. Sam Eldabe, Consultant in Anaesthesia and Pain Management at James Cook University Hospital in Middlesbrough, the U.K. "Overall, this technology appraisal -- and the resulting guidance -- will be an important resource demonstrating the efficacy and cost-effectiveness of SCS as a treatment for chronic pain worldwide."
The recommendation paves the way for better patient access to SCS therapy. The NHS in England and Wales is directed to provide funding and resources for NICE-approved technologies normally within three months of publication date.
The NICE appraisal reviewed the clinical data available for patients with either Failed Back Surgery Syndrome or Complex Regional Pain syndrome(1). It concluded that the trial data provided solid clinical evidence that SCS is an effective treatment for neuropathic pain. As a result, NICE has formally recommended SCS as an effective treatment for adult patients in England and Wales who have suffered chronic pain of neuropathic origin for at least six months, despite conventional medical management.
NICE noted that any medical assessment recommending SCS should involve a multidisciplinary team experienced in treatment of chronic pain and should take into account patient needs and severity of pain. In order to select the appropriate SCS system, patients' stimulation requirements and anticipated longevity of device use should also be considered. SCS is not recommended as a treatment option for adults with chronic pain as a result of ischemia except in a clinical trial setting where it may prove useful in this indication.
Neuropathic pain is a debilitating form of chronic pain resulting from injury to the peripheral or central nervous system. Chronic pain is one of the most underestimated health care problems, with estimates of prevalence varying widely(2). Currently, conventional treatments to alleviate chronic neuropathic pain combine different therapies that may include drugs (such as anti-depressants and opiates), non-pharmacological treatments (such as physiotherapy and acupuncture) or surgical intervention.
Boston Scientific's Precision(TM) SCS neuromodulation system is engineered to precisely target pain and maintain therapy over time, and it is designed to fit a patient's lifestyle. The small device is implanted under the skin and provides pain relief by delivering electric signals that mask the pain by inducing a tingling sensation. Patients can control their treatment using a remote control device that activates the implant.
"At Boston Scientific, we pride ourselves on delivering innovative treatments that can change patients' lives," said David McFaul, Boston Scientific Senior Vice President, International. "Our Precision spinal cord stimulation system is rechargeable and combines breakthrough technology with features designed to enhance patient convenience. It allows pain specialists to offer cost-effective treatments for chronic pain and help improve the quality of patient care."
The Precision SCS system was launched in the United States in 2004 and in Europe in 2005. To date more than 20,000 Precision SCS systems have been implanted worldwide. The Precision SCS system is distributed by Boston Scientific's Neuromodulation group.
The National Institute for Health and Clinical Excellence is an independent organization that provides recommendations on the use of new and existing medicines and treatments in England and Wales. For more information, please visit: (http://www.nice.org.uk).
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific-international.com.
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1. National Institute for Health and Clinical Excellence (NICE). Spinal
Cord Stimulation for chronic pain of neuropathic and ischemic origin.
Technology appraisal No. TA-159 (October 2008). London: NICE, 2008.
2. Torrance T, Smith BH, Bennett MI, Lee AJ. The epidemiology of chronic
pain of predominantly neuropathic origin. Results from a general
population survey. J Pain 2006;7(4):281-9.
CONTACT: Paul Donovan
Boston Scientific Corporation
Boston Scientific Corporation
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