ST. PAUL, Minn., Feb 03, 2010 (BUSINESS WIRE) —-St. Jude Medical, Inc. (NYSE:STJ) today announced the U.S. Food and Drug Administration (FDA) clearance of the Swift-Lock(TM) anchor, a new product designed to help physicians efficiently secure neurostimulation leads utilized in spinal cord stimulation (SCS) therapy for the management of chronic pain. Introduced at the American Academy of Pain Medicine (AAPM) annual meeting, the Swift-Lock anchor builds on a 30-year history of developing industry-leading neurostimulation products.
Designed to reduce anchoring time and enhance procedural efficiency, the Swift-Lock anchor eliminates the need for sutures or medical adhesive typically required to secure the anchor to the lead. Featuring an easy-to-use mechanical lock, physicians secure the anchor with a simple 90-degree twist. This design minimizes the complexity and variability associated with anchoring leads.
“For more than 30 years we have focused on the development of the most advanced line of clinically relevant neurostimulation products to meet the needs of physicians and patients,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “The Swift-Lock anchor is yet another example of our commitment to provide best-in-class solutions to aid in the management of chronic pain.”
The Swift-Lock anchor features include:
— Intuitive locking mechanism that provides tactile and visual confirmation that the lead is locked
— Strong fixation to the lead to help mitigate the risk of migration
— Highly radiopaque material to provide easy fluoroscopic visualization
— Simple twist lock mechanism allows for easy repositioning of the lead if needed
Three decades of leading edge neurostimulation technology For more than 30 years, the St. Jude Medical Neuromodulation Division has developed new technologies to treat chronic pain and other neurological disorders. Today more than 60,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems.
Some of the innovative products that St. Jude Medical was first to bring to market include:
— World’s smallest neurostimulator for chronic pain — the Eon Mini(TM) spinal cord stimulator
— First-of-its-kind five-column paddle lead — the Penta(TM) lead
— Next-generation programming platform used to optimize neurostimulation therapy — MultiSteering(TM) Technology software for Rapid Programmer(TM)
— First spinal cord stimulator with constant current circuitry — the Genesis(TM) neurostimulator
— World’s smallest, longest-lasting rechargeable deep brain stimulation (DBS) device for treating the symptoms of Parkinson’s disease — the Brio(TM) neurostimulator (CE Mark approval)
Focused on research, St. Jude Medical is developing new technologies to address a growing list of neurological disorders. Clinical studies are currently underway for Parkinson’s disease, essential tremor, migraine headaches, major depressive disorder, and others.
Spinal cord stimulators are implanted neurostimulation devices that send mild electrical pulses from an implanted device to leads that are placed in the epidural space. These low intensity pulses interrupt the pain signals’ pathways to the brain by stimulating selective nerve fibers along the spinal cord. More information can be obtained about neurostimulation therapy at www.PowerOverYourPain.com.
Chronic pain affects millions of patients worldwide. In the U.S., more than 76.5 million people are categorized as suffering from chronic pain by the American Pain Foundation. Estimates by the National Institutes of Healthplace the costs for lost work time and healthcare expenses at approximately $100 billion every year.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit 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 Risk Factors and Cautionary Statements sections of the Company’s Quarterly Reports on Form 10-Q for the fiscal quarters ended April 4, 2009, July 4, 2009 and October 3, 2009. 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, Inc.
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