St. Jude Medical Eon and Eon Mini News and Recall Information

St. Jude Medical Announces Approval of the First Rechargeable Neurostimulator to Manage Chronic Pain in Japan

Sep 30

Written by:
9/30/2010 3:22 PM  RssIcon

The Eon Mini spinal cord stimulator -- world's smallest, longest-lasting rechargeable neurostimulator to manage chronic pain -- combines greater patient comfort with 10-year battery longevity 

ST. PAUL, Minn., Sep 30, 2010 (BUSINESS WIRE) --

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) of the Eon Mini(TM) spinal cord stimulation (SCS) system. The world's smallest, longest-lasting rechargeable neurostimulator, the Eon Mini device is the first rechargeable spinal cord stimulator to be approved for use in Japan. Spinal cord stimulators manage chronic painof the trunk or limbs and pain from failed back surgery by delivering mild electrical pulses to the spinal cord, which interrupt or mask the pain signals' transmission to the brain.

Slightly larger than the typical man's watch, the Eon Mini neurostimulator has a thin 10 mm profile and weighs 29 grams (approximately 1 oz). Additionally, the device has the greatest recommended implant depth of any rechargeable SCS device. The thin profile and greater implant depth potentially makes the neurostimulator less noticeable and more comfortable for patients. Its small size also allows for a smaller incision, which gives physicians increased flexibility in selecting the implant location.

"Neurostimulation offers chronic pain patients a therapy that can deliver sustainable relief," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division."The Japanese approval of the Eon Mini neurostimulator represents an important step toward broadening the availability of this therapy."

Even with its small size, the Eon Mini neurostimulator has the longest-lasting battery life of any rechargeable spinal cord stimulation device currently on the market. It is the only small rechargeable neurostimulator to receive a 10-year battery longevity approval. This means the device should provide sustainable therapy and maintain a reasonable recharge interval for at least 10 years of use at high settings. The device's battery longevity also may mean that patients require fewer battery replacement surgeries.

In addition, the Eon Mini device features the following:

  • Advanced programming capability that allows physicians to manage up to eight pain areas simultaneously to address complex pain patterns.
  • A 16-contact header that is compatible with all St. Jude Medical neurostimulation leads, giving physicians more control in designing the system for optimal pain relief.
  • Enhanced microchip and software (NeuroDynamix(TM)) 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.
  • Fully portable charging system that allows patients the freedom to comfortably recharge the battery while taking a walk, cooking a meal or shopping.

"With the Eon Mini neurostimulator we are now able to offer physicians a best-in-class product to help them meet the needs of patients who require a smaller, long-lasting rechargeable system in order to manage their chronic pain," said William Phillips, president of St. Jude Medical Japan. "The launch of the Eon Mini spinal cord system -- the first rechargeable technology in Japan -- is an excellent addition to our growing portfolio of neurostimulation products available from St. Jude Medical Japan."

Chronic pain is a largely under-treated and misunderstood condition that affects millions of patients worldwide. The World Health Organization, in conjunction with the International Association for the Study of Pain (IASP), reports that as many as one in five people suffers from moderate to severe chronic pain.

Three decades of leading edge neurostimulation technology

More than 75,000 patients in 40 countries have been implanted with St. Jude Medical neurostimulation systems. Patients can obtain more information about neurostimulation therapy at www.PowerOverYourPain.com orwww.sjm.co.jp/general/nerve/index.html.

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. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit 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, 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 Report on Form 10-Q for the fiscal quarter ended April 3, 2010. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

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SOURCE: St. Jude Medical, Inc.

St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations:
Denise Landry, 972-309-8085
dlandry@sjm.com

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