PRECISION™ PLUS SPINAL CORD STIMULATOR System Receives CE Mark Approval for Peripheral Nerve Stimulation
Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for use of its PRECISION™ PLUS SPINAL CORD STIMULATOR (SCS) System, the world's first rechargeable SCS device, in peripheral nerve stimulation for patients with chronic intractable pain of the trunk. Peripheral nerve stimulation provides physicians and patients with an additional treatment option for managing chronic intractable pain of the trunk by stimulating peripheral nerves through a small surgically implantable device.
"I am pleased to learn the PRECISION PLUS SCS System has received CE Mark approval for peripheral nerve stimulation," said Dr. David Abejón, consultant anaesthetist at Hospital Universitario Puerta de Hierro Majadahonda, Madrid. "Based on my clinical experience and research with peripheral nerve stimulation therapy to date, this technique seems to be a promising treatment option in the field of chronic intractable pain management."
Chronic intractable pain is continuous pain has lasted more than six months. Living in constant pain for an extended period time can have a devastating impact to quality of life for many patients. Without relief, or the hope for relief, many patients lose the ability to sleep, work, and function normally.
"Chronic pain affects nearly 95 million adults throughout Europe," said Michael Onuscheck, senior vice president and president of Europe, Middle East and Africa at Boston Scientific. "Expanding our neuromodulation portfolio to include peripheral nerve stimulation with the PRECISION PLUS SCS System continues our commitment to providing physicians and patients with multiple treatment options for the management of this debilitating condition."
About the PRECISION PLUS SCS System
The PRECISION PLUS SCS System was approved in the United States in 2004 and received approval in Europe and Canada in 2005. The system is the world's first rechargeable implantable pulse generator. Today, more than 60,000 patients worldwide have been treated using this system. When compared to non-rechargeable SCS systems, rechargeable SCS systems may offer clinical benefits by extending therapeutic longevity and therefore avoiding frequent replacement surgeries and complications that may arise from repeated surgeries.
All cited trademarks are the property of their respective owners. Caution: The law restricts these devices to sale by or on the order of a physician. Inactions, contraindications, warnings, and instructions for use can be found on the product labeling supplied with each device. Information is for use only in countries with applicable health authority product registrations.
About Boston Scientific Neuromodulation
Boston Scientific Neuromodulation is an innovation leader in implantable pain management technology. Through its investments in technology, clinical science, and world-class service, Boston Scientific Neuromodulation is committed to making life smoother for physicians and patients. For more information on the PRECISION PLUS SCS System technology, visit https://www.ControlYourPain.com.
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 30 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 our business plans, clinical trials and the importance of their results, 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.