Healthcare Industry News:  neuromodulation 

Devices Regulatory

 News Release - January 17, 2007

Advanced Neuromodulation Systems Receives European Approval for Rapid Programmer(R) 3.0 Clinician Programming Platform

Approval Coincides with Launch of Enhanced Rechargeable Spinal Cord Stimulation Device

PLANO, Texas--(HSMN NewsFeed)--Advanced neuromodulation Systems (ANS), the neuromodulation business of St. Jude Medical, Inc. (NYSE:STJ ), today announced European CE Mark approval for its newest clinician programming platform, Rapid Programmer 3.0 for spinal cord stimulation (SCS), an advanced therapy for managing chronic pain.

Coinciding with this approval, ANS has launched an upgraded version of its rechargeable spinal cord stimulation device, the EonŽ with NeuroDynamix technology. The Eon's proprietary new microchip and enhanced software, together with Rapid Programmer 3.0, create a sophisticated system to provide patients with customized pain coverage.

Spinal cord stimulators like Eon are used to treat patients suffering with chronic intractable pain. These "pacemakers for pain" interrupt the pain signals' pathway to the brain by delivering low intensity electrical pulses to selective nerve fibers along the spinal cord. More than 30,000 patients worldwide have been implanted with ANS neurostimulation systems to help alleviate their chronic pain.

"The enhanced Eon and the new Rapid Programmer platform work together as an integrated system to provide clinicians greater speed, power, efficiency and precision for helping patients address complex pain," said Chris Chavez, president of Advanced neuromodulation Systems.

Rapid Programmer 3.0 features two new technologies for delivering stimulation to pain patients:
  • Dynamic MultiStim(TM) - This technology allows for real-time programming adjustments to multiple areas of pain, which better targets pain coverage and decreases programming time. This is especially useful when patients have complex pain patterns, such as a combination of back and leg pain.

  • Active Balancing(TM) - This capability lets patients and clinicians easily fine-tune stimulation levels in multiple coverage areas, quickly establishing relief and giving patients sophisticated, yet easy-to-use, control over their therapy.
The upgraded Eon stimulator provides the longest time between recharges available today giving patients added flexibility in their recharging schedule. Additionally, the new Eon has market-leading power output, supplying 25 percent more power than its predecessor and enabling it to meet the varying power requirements of individual patients. The device also has the highest frequency capability on the market, allowing it to serve patients who need higher frequencies to control their pain.

More information for clinicians is available at www.ans-medical.com/dynamicduo.com.

About ANS, the neuromodulation Business of St. Jude Medical

Advanced neuromodulation Systems (ANS) 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.

Forward-Looking Statements

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, regulatory approvals, anticipated future product launches, 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

Issuer of this News Release is solely responsible for its content.
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