News | May 19, 2016

Boston Scientific Receives U.S. FDA Approval For Precision Montage MRI Spinal Cord Stimulator System

Full-Body MRI Access Expands Spinal Cord Stimulation Offering and Brings Customized Therapy to More Patients Suffering from Chronic Pain

Marlborough, MA (PR Newswire) - Boston Scientific Corporation (NYSE: BSX) today announced the launch of the Precision Montage™ MRI Spinal Cord Stimulator (SCS) System after receiving approval from the U.S. Food and Drug Administration. The Precision Montage System offers customized relief to patients with chronic pain while also enabling safe access to full body magnetic resonance imaging (MRI) in a 1.5 Tesla environment when conditions of use are met. Boston Scientific is introducing the system at the 8th World Congress of the World Institute of Pain in New York City on May 20-23, 2016.

More than 100 million Americans suffer from chronic pain, which can have a devastating impact on quality of life. Patients with pain sometimes experience a fluctuation in location, type and intensity of pain throughout the day or over time. The Precision Montage MRI SCS System allows patients to undergo a full-body MRI while benefiting from the pain relief of MultiWave™Technology. MultiWave Technology enables delivery of multiple waveforms, including burst and higher rates, intended to help respond to changes in pain over time. In an analysis of registry information from 800 patients, it was determined that 72 percent used multiple waveforms to customize their therapy and optimize pain relief.

The new SCS system also expands the suite of Boston Scientific products that leverage the Illumina 3D™ algorithm, a three-dimensional, anatomy-driven computer model designed for simple point-and-click pain targeting to support physicians in treating chronic pain. In addition to the new Precision Montage MRI SCS System, the portfolio includes the Precision Spectra™ System, which is designed to provide broad coverage for pain with 32 contacts, and thePrecision Novi™ System, the smallest high-capacity non-rechargeable device. The LUMINA clinical study has demonstrated 70 percent greater low-back pain relief with the SCS system in the Illumina 3D family, which was maintained out to 24-months.1

“The Boston Scientific Illumina 3D portfolio allows me to tailor therapy for each patient consistently and effectively,” said Salim Hayek, M.D., Ph.D., program director, Anesthesiology Pain Medicine, University Hospital Case Medical Center, Cleveland, Ohio. “With the approval of the Precision Montage MRI SCS System, more of my patients can benefit from this powerful technology since they can now have access to future MRI scan needs.”

“The Precision Montage MRI SCS System is a key addition to our Illumina 3D portfolio, offering patients more choices to manage and personalize their therapy,” said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. “This important advancement underscores our commitment to meet the individual needs of chronic pain patients.”

For more product and important safety information, please visit the Precision Montage MRI SCS System product page.

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, visitwww.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 regulatory approvals, new 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 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.

1Boston Scientific LUMINA data presented at the 19th annual meeting of the North American Neuromodulation Society

SOURCE: Boston Scientific