Healthcare Industry News: neurostimulation
News Release - February 15, 2007
St. Jude Medical Announces FDA Clearance of Spinal Cord Stimulation Leads for Patients with Low Back PainTripole 16C helps physicians customize care with 16 independent electrodes
ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ), today announced U.S. Food and Drug Administration (FDA) clearance of two spinal cord stimulation tripolar paddle leads for use with the Renew® neurostimulation System. With three columns of electrodes, these leads allow physicians more programming options to address complex pain patterns.
The leads were developed by St. Jude Medical's neuromodulation division, Advanced Neuromodulation Systems (ANS).
The Lamitrode Tripole(TM) 16C and the Lamitrode Tripole 8C are designed to help patients suffering from one of the most common and difficult-to-treat patient indications, neuropathic low back pain. Often described as an intense burning or stabbing pain, neuropathic pain can be caused by an injury to nerves or by an underlying disease or dysfunction.
The Tripole 16C is the first three-column paddle lead with 16 independently activated electrodes, which can be programmed to send mild electrical pulses to low back nerve fibers while minimizing unwanted stimulation. These independent electrodes can also be programmed to provide stimulation to multiple areas for those patients who have pain in more than one area of the body.
"Low back pain is one of the most difficult pain patterns to treat," said Gerald Hale, D.O., of Tulsa Integrated Pain Services in Tulsa, Okla. "The development of these new paddle leads improves our ability to treat this area through targeted, sustainable stimulation therapy." Dr. Hale was one of the first to evaluate the design of these leads.
In 2004, ANS was the first to introduce a tripolar paddle lead. The Tripole 16C and Tripole 8C are the first tripolar leads with a curved surface to conform to the cylindrical shape of a patient's spine, which is designed to make them more stable and less prone to migration.
"We are committed to developing new lead technology that provides physicians with the widest array of lead options, so they can choose the best lead to address each patient's need," said Chris Chavez, president of ANS.
Pain is a serious and costly public health issue, and it remains largely under-treated and misunderstood. According to the National Institutes of Health, 90 million people in the U.S. suffer from chronic pain. The American Pain Foundation estimates that chronic pain costs approximately $100 billion a year in lost work time and health care. More than 30,000 patients in 25 countries have been implanted with ANS spinal cord stimulation systems to treat chronic pain of the trunk and limbs.
About ANS, the Neuromodulation Division of St. Jude Medical
Advanced Neuromodulation Systems is an innovative technology leader dedicated to the design, development, manufacturing and marketing of implantable neuromodulation systems to improve the quality of life for people suffering from disabling chronic pain and other nervous system disorders. Based in Plano, Texas, ANS (www.ans-medical.com) is a division of St. Jude Medical.
About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 11,000 people worldwide. For more information, please visit www.sjm.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and in the Company's Quarterly Reports on Form 10-Q filed on August 7, 2006 (see Item 1A on page 32) and November 7, 2006 (see pages 31-32). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Source: St. Jude Medical
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