Newswise — St. Jude Medical, Inc. (NYSE:STJ) today announced the first patient implant of an Eon Miniâ„¢, the world's smallest, longest-lasting, rechargeable neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery.
A 26-year-old patient was implanted with the Eon Mini neurostimulator, a medical device which is slightly larger than a U.S. silver dollar. Similar in function and appearance to a cardiac pacemaker, the neurostimulator delivers mild electrical pulses to the spinal cord, which interrupt or mask the pain signals' transmission to the brain.
The patient, Adam Hammond, is a former member of the U.S. Army "Golden Knights" Parachute Team. Hammond was skydiving while on leave in 2006 when his parachute did not deploy correctly. He hit the ground in excess of 45 miles an hour.
"As soon as I hit the ground, I thought, 'God, please don't let me die,'" said Hammond of Chillicothe, Ohio, whose numerous injuries included a broken femur, shattered pelvis and a severed spine. He spent the next two years undergoing multiple surgeries and physical therapy, but chronic pain from his injuries impacted his rehabilitation.
"Neurostimulation helps us control Adam's pain so he can continue his rehabilitation and decrease his pain medications," said Tim Deer, M.D., president and CEO, Center for Pain Relief in Charleston, W.Va. "Our main goal is to use spinal cord stimulation to help him return to his everyday activities and become a vital part of society again."
The Eon Mini neurostimulator has a thin 10 mm profile and weighs 29 grams (approx. 1.0 oz). Its small size allows for a smaller incision, giving the physician increased control and flexibility in selecting the implant location.
Even with its small size, the Eon Mini neurostimulator 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 life approval by the U.S. Food and Drug Administration (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 may also mean that patients require fewer battery replacement surgeries.
Because the charging system is fully portable, the Eon Mini neurostimulator allows patients the freedom to comfortably recharge the device's battery while taking a walk, cooking a meal or shopping.
"I already have significant pain relief," said Hammond. "I'm now able to walk twice as far, and I recently went to the movies with my best friend. It feels good to start getting my life back."
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 per year in lost work time and healthcare expenses.
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 http://www.PowerOverYourPain.com.
The Eon Mini neurostimulator has received FDA and European CE Mark approvals. The device will be available this fall (2008).
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 12,500 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit http://www.sjm.com.
About the ANS Division of St. Jude Medical
The ANS Division (Advanced Neuromodulation Systems) became a 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 (http://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 Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K filed on February 27, 2008. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
RSS