Healthcare Industry News:  neurostimulator 

Devices FDA

 News Release - April 14, 2008

St. Jude Medical Receives FDA and CE Mark Approvals for the World's Smallest, Longest-Lasting Rechargeable Neurostimulator to Treat Chronic Pain

Eon Mini Combines Greater Patient Comfort With 10-Year Battery Longevity

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) and European CE Mark approvals of Eon Mini™, the world’s smallest, longest-lasting rechargeable neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery.

Slightly larger than the circumference of a U.S. silver dollar, the Eon Mini neurostimulator has a thin 10 mm profile and weighs 29 grams (approximately 1.0 oz.). Its small size allows for a smaller incision, which gives physicians increased flexibility in selecting the implant location and is intended to make the site less visible and more comfortable for patients.

“Device size is an important consideration for many patients. The thin, small design should increase patient comfort, making it ideal for those whose body type requires a small device,” said Steven Rosen, M.D., of Fox Chase Pain Management Associates in Philadelphia, Pa. “Along with its dimensions, the device’s ability to provide high power output and long periods between recharges should make this an appealing option for many patients.”

Even with its small size, the Eon Mini has the longest-lasting battery life of any rechargeable spinal cord stimulation (SCS) device in its class. It is the only small rechargeable neurostimulator to receive a 10-year battery longevity approval by the FDA. For patients this means the device should provide sustainable therapy and maintain a reasonable recharge interval for 10 years of use at high settings. The device’s battery longevity also may mean that patients require fewer battery replacement surgeries.

The Eon Mini also allows patients the freedom to comfortably recharge the device’s battery while taking a walk, cooking a meal or shopping because the charging system is fully portable. Additionally, Eon Mini has the greatest recommended implant depth of any small rechargeable SCS device, so the device can be placed more discreetly, potentially making it less noticeable.

In addition, the Eon Mini device features the following:
  • Enhanced microchip and software (NeuroDynamix™) technology that continuously selects the most efficient power management mode, preserving the battery’s capacity to deliver therapy.
  • Constant current circuitry that automatically adjusts power output to deliver consistent therapy over time.
  • Advanced programming capability that allows physicians to treat up to eight pain areas simultaneously to address complex pain patterns.
  • A 16-contact header that is compatible with all St. Jude Medical SCS leads, giving physicians more control in designing the system for optimal pain relief.
“The Eon Mini reflects our commitment to developing clinically relevant products to meet the needs of chronic pain patients,” said Chris Chavez, president of St. Jude Medical’s ANS Division. “Not only is Eon Mini the smallest, longest-lasting rechargeable neurostimulator available, it gives physicians and their patients more choices and more control in optimizing sustainable therapy.”

The Eon Mini design is based on the field-proven platform of the Eon® neurostimulator and almost three years of performance data and improvements to the device. It will be available in both the U.S. and Europe in the third quarter of 2008.

neurostimulators like the Eon Mini and Eon are similar in function and appearance to cardiac pacemakers, delivering mild electrical pulses to the spinal cord, which interrupt or mask the pain signals’ transmission to the brain. More than 35,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems. Patients can obtain more information about neurostimulation pain therapies at www.PowerOverYourPain.com.

Chronic pain is a serious public health issue that remains largely under-treated and misunderstood. According to the National Institutes of Health, 90 million people in the U.S. suffer from chronic pain. In Europe, the World Health Organization estimates that one in five people live with chronic pain of moderate severity.

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 12,000 people worldwide. For more information, please visit www.sjm.com.

About the ANS Division of St. Jude Medical

The ANS Division (Advanced Neuromodulation Systems) became part of St. Jude Medical in 2005. The ANS Division 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 (www.ans-medical.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, 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 February 27, 2008 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company’s Form 10-K). 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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