ST. PAUL, Minn.--St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today announced European CE Mark approval of its Brio™, Libra™ and LibraXP™ deep brain stimulation (DBS) systems for managing the symptoms of intractable primary and secondary dystonia, a neurological movement disorder that causes a person's muscles to contract and involuntarily spasm, reducing the ability to control movement. This approval represents the first by a regulatory agency for the use of deep brain stimulation to manage both primary and secondary dystonia.
"Dystonia strikes people of all ages including children and young adults, often leaving them disabled and sometimes wheelchair-bound," said Elena Moro, Ph.D., professor of neurology at the University Hospital Center of Grenoble, France. "For patients who do not respond to medications, deep brain stimulation therapy may alleviate symptoms such as repetitive, twisting movements, allowing them to improve their independence and overall quality of life."
DBS therapy for dystonia involves the delivery of mild electrical pulses to a specific target in the brain. Stimulation is delivered to one of two regions, the subthalamic nucleus (STN) or the globus pallidus interna (GPi), areas of the brain involved with controlling movement. Irregular nerve signals responsible for some of the disabling symptoms are stimulated by DBS therapy, ultimately helping the patient improve movement.
"This CE Mark is the first approval by a regulatory agency for the use of deep brain stimulation therapy to manage the symptoms of both primary and secondary dystonia, broadening the treatment options for patients in Europe whose lives are impacted by this disabling disease," said Eric S. Fain, M.D., president of the St. Jude Medical Implantable Electronic Systems Division. "This approval represents a significant milestone for St. Jude Medical as we continue to develop therapies to treat a broad range of neurological conditions."
Dystonia is an incurable neurological movement disorder thought to affect more than 500,000 people across Europe. Primary dystonia is defined as an illness in which the origin of the disease is unknown, and may be genetically inherited. Secondary dystonia is considered environmental or symptomatic as it often results from another condition such as a stroke, or as a response to certain medications such as dopamine blocking drugs used to treat psychiatric disorders. Onset of secondary dystonia can also result from an injury or trauma to the brain. To learn more, visit http://dystonia-europe.org/.
About Deep Brain Stimulation (DBS)
DBS for movement disorders has been used to manage the symptoms of Parkinson's disease for more than 15 years. To implant a DBS system, a neurosurgeon places two thin leads with small electrodes into a specific area in the brain. The leads are then connected to a power source that is placed just under the skin near the pectoral muscle in the chest, delivering a constant series of painless pulses, which influence the signals causing the disabling symptoms. The system is programmed to meet the unique needs of each individual patient and can be adjusted as symptoms change or the disease progresses. DBS therapy does not destroy or remove parts of the brain like other surgical treatments used for movement disorders.
St. Jude Medical's Brio neurostimulator is the world's smallest DBS device. Slightly larger than the face of a typical man's watch, the Brio neurostimulator has a thin 10 mm profile and features the greatest recommended implant depth of any rechargeable DBS device. The thin profile and greater implant depth potentially makes the neurostimulator less noticeable and well suited for patients with a small body type. The Brio rechargeable neurostimulator is also the longest-lasting rechargeable DBS device on the market and has a 10-year battery life. Additionally, the Libra and LibraXP non-rechargeable DBS devices have forty-percent more battery capacity than any neurostimulators in their class to maximize time between device replacement procedures.
St. Jude Medical DBS therapy is also approved in Europe and Australia for the treatment of the disabling symptoms of Parkinson's disease. Additionally, the company is evaluating DBS therapy in clinical studies for depression and essential tremor. St. Jude Medical DBS systems are not approved for use in the U.S.
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.
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 for the fiscal year ended December 29, 2012. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.