"Boston Scientific Corporation NYSE BSX today announced that the U.S. Food and Drug Administration FDA has approved the Spectra WaveWriter Spinal Cord Stimulator SCS System. It is the first and only system approved by the FDA to simultaneously provide paresthesiabased and subperception therapy. The system allows physicians and patients to combine therapeutic options customize therapy and capture realtime feedback designed to treat chronic and debilitating pain successfully.  SCS works by sending low electrical pulses which vary in frequency pulse width and amplitude to the spinal cord to interrupt pain signals. Paresthesiabased therapy provides pain relief with a light tingling sensation while subperception therapy works without that sensation. With the Spectra WaveWriter System patients can choose to combine both of these therapies to target one specific area of pain or use each therapy as needed to best manage multiple areas of pain. Patients provide realtime feedback using the systems remote control. Together these features benefit patients by addressing each individuals unique pain relief needs. Patients suffering with chronic pain experience pain differently and pain also evolves over time sometimes causing a patient to become less responsive as the body becomes accustomed to treatment said Dr. Giancarlo Barolat neurosurgeon Barolat Neuroscience Denver Colorado. Until now the medical community has had limited options to offer personalized pain relief therapy to patients. The main advantage of the Spectra WaveWriter System is that it integrates multiple therapies into a single device so that treatment can more easily be tailored to individual needs. The Spectra WaveWriter System was developed with more than a decade of clinical research focused on optimizing subperception and delivering multiple therapies intended for more effective longterm pain relief. These studies include the WHISPER study and the PROCO study. The PROCO study was a multicenter prospective doubleblind randomized study in which patients acted as their own control. This study established in de novo patients that similar pain relief and improvement in quality of life measures are achieved independent of the type of frequency from  kHz up to  kHz used in subperception SCS therapy when the proper target and dose are identified. The WHISPER study is a multicenter prospective crossover randomized and controlled study evaluating the longterm safety and effectiveness of subperception SCS pain relief therapy. We are introducing industryleading SCS technology to help provide patients with lasting relief from chronic pain said Maulik Nanavaty president and senior vice president Neuromodulation Boston Scientific. We are committed to investing in research and expanding treatment options for chronic pain by identifying new nonopioid solutions for the millions of people suffering from this debilitating condition. More than  million Americans suffer from chronic pain and it is the number one cause of disability in adults in the U.S. SCS is a nonopioid alternative for treating chronic pain. While prescriptions for opioids have quadrupled since  the amount of pain reported in the U.S. has not changed.   About 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  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  http and connect on Twitter httpstwitter.combostonsci and Facebook https  Cautionary Statement Regarding ForwardLooking Statements  This press release contains forwardlooking statements within the meaning of Section A of the Securities Act of  and Section E of the Securities Exchange Act of . Forwardlooking statements may be identified by words like anticipate expect project believe plan estimate intend and similar words. These forwardlooking 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 forwardlooking statements include among other things statements regarding our product launches 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 forwardlooking 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 forwardlooking statements.  Factors that may cause such differences include among other things future economic competitive reimbursement and regulatory conditions new product introductions demographic trends the closing and integration of acquisitions 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 A  Risk Factors in our most recent Annual Report on Form K filed with the Securities and Exchange Commission which we may update in Part II Item A  Risk Factors in Quarterly Reports on Form Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forwardlooking 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 forwardlooking statements. This cautionary statement is applicable to all forwardlooking statements contained in this document.  . https  . Institute of Medicine. Relieving pain in America a blueprint for transforming prevention care education and research. Washington DC National Academies Press .  . http_guideline_for_prescribing_opioids_for_chronic_paina.pdf"