Boston Scientific Corporation

Boston Scientific Announces CE Mark Approval and European Launch for New Infinion? 16 Percutaneous Lead for Precision Plus? Spinal Cord Stimulator System

Paris and Miami Beach, Florida (ots/PRNewswire) - Boston Scientific Corporation announces CE Mark approval of the Infinion(TM) 16 Percutaneous Lead for its Precision Plus(TM) Spinal Cord Stimulator (SCS) System, the first rechargeable SCS device for chronic pain management. The first patient implant in Europe using the Infinion(TM) 16 Lead was performed by Kliment Gatzinsky, M.D., Ph.D., and David Revesz, M.D., of the Neurosurgery Department atthe Sahlgrenska University Hospital in Guldheden, Sweden.

The Infinion 16 Lead is the world's first and only 16-contact percutaneous lead and the latest innovation in Boston Scientific's comprehensive percutaneous lead portfolio. The Company announced the approvaltoday at the World Institute of Pain (WIP) Congress, which runs from February 4 - 6 in Miami Beach. The Infinion 16 Lead is currently commercially available in the U.S. and will be introduced in CE Mark countries immediately.

SCS leads are designed to deliver electrical pulses from an implantable pulse generator to the spinal cord to mask pain signals to the brain (known as paresthesia). Until now, percutaneous leads have offered a maximum of eight stimulating contacts. By providing twice the number of contacts than any previous percutaneous lead, the Infinion 16 Lead is designed to offer more coverage of the spinal cord for the management of chronic pain.

"I appreciate that for the first time, it is possible to place 16 contacts with a single percutaneous lead using a small insertion needle," said Dr. Gatzinsky. "This lead will provide me with more options to optimize the paresthesiacoverage to bring relief for chronic pain patients." Dr. Revesz added, "The Infinion 16 Lead is very responsive, with excellent steering that allows easy placement in the target area."

Chronic pain is a debilitating condition that affects approximately 138 million people in Europe or more than one in five adults.[1] Tens of thousands of patients with chronic pain have found that SCS systems help them manage their pain. SCS is a reversible therapy that manages pain through an implantable pulse generator and external devices that control therapy and charge theimplant.

"The Infinion 16 Lead is the latest advance in SCS lead technology and an exciting addition to our unrivaled percutaneous lead portfolio," stated Maulik Nanavaty, Senior Vice President and President of the Boston Scientific Neuromodulation Division. "We believe that the European launch of the Infinion 16 Lead, coupled with increased awareness of pain management treatment alternatives, will allow us reach a wider patient population. Boston Scientific continues its commitment to innovation by offering pain management physicians more choices to help optimize pain relief for their patients."

About Boston Scientific Neuromodulation

Boston Scientific Neuromodulation is an innovation leader in implantable pain management technology. The Precision Plus Spinal Cord Stimulator System, powered by SmoothWave Technology, uses pulses of electricity delivered directly along nerve fibers through the spinal cord to mask pain signals to the brain. Through investments in technology, clinical science, and world-class service, Boston Scientific Neuromodulation is committed to Making life smoother(TM) for physicians and patients. For more information on Precision Plus technology, visit:

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:

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 new product launches and launch cadence, future innovation, product performance and competitive offerings. 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. United Nations World Population Monitoring 2001. United Nations Publication, 2001;1-80.


Simonetta Balbi, PR and Corporate Communication EMEA,
Boston Scientific, Mobile +39-3387936422, Office +39-02-269831

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