ST. PAUL, Minn.–(BUSINESS WIRE)– St. Jude Medical, Inc., een internationaal bedrijf in medische apparatuur, heeft vandaag bekendgemaakt dat de Amerikaanse Food and Drug Administration (FDA) zijn systeem voor diepe breinstimulatie (DBS), Infinity™ en bijbehorende directionele geleidingsdraden heeft goedgekeurd. Het systeem is ook voor het eerst geïmplementeerd. Het systeem van St. Jude Medical bevat daarmee de eerste directionele geleidingsdraden die zijn goedgekeurd in de Verenigde Staten. Infinity biedt patiënten met Parkinson of essentiële tremor en artsen een discrete, gepersonaliseerde ervaring in combinatie met het eerste en enige draadloze iOS™ -softwareplatform voor DBS-patiënten. Daarbij biedt Infinity alleen in de noodzakelijke gebieden doelgerichte hulp.
St. Jude Medical Announces U.S. Launch and First Implant of New Deep Brain Stimulation System and Directional Lead for Patients Suffering from Movement Disorders
The St. Jude Medical Infinity™ Deep Brain Stimulation (DBS) system with directional lead technology is designed to help patients with Parkinson’s disease or essential tremor gain control of their symptoms
ST. PAUL, Minn.–(BUSINESS WIRE)– St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the United States Food and Drug Administration approval and first implant of the St. Jude Medical Infinity™ Deep Brain Stimulation (DBS) system and its DBS directional leads, the first directional lead approved in the United States. Combined with the first and only wireless iOS™ software platform available to DBS patients and physicians, the St. Jude Medical Infinity system provides a discreet, personalized experience for patients suffering from Parkinson’s disease or essential tremor, while delivering targeted relief of only the necessary areas.
The Infinity DBS system was first implanted by Dr. Kelly Foote, professor of neurosurgery and co-director of the University of Florida Center for Movement Disorders and Neurorestoration at the UF Health Shands Hospital.
Speaking about the new technology, Foote said, “I’m very happy that the Infinity DBS system and its directional DBS lead are now available in the U.S. I believe that the directional lead represents an important advancement in DBS technology that has the potential to improve outcomes of DBS therapy for many patients. This new system offers the potential to diminish adverse effects of DBS by steering current away from areas of the brain that cause side effects, allowing us to better control the symptoms of Parkinson’s disease and essential tremor.”
The St. Jude Medical Infinity system is indicated to treat two of the most common movement disorders — Parkinson’s disease and essential tremor. Movement disorders are neurological conditions caused by a communication breakdown throughout the central nervous system that can result in a debilitating loss of muscle control, involuntary movement and reduced coordination. There are currently no proven cures for movement disorders, which means treatment options focus on alleviating symptoms to improve quality of life.
“The new St. Jude Medical Infinity DBS system is an advanced technology that has the potential to provide more choices to patients with Parkinson’s disease and essential tremor,” said Dr. Michael S. Okun, chairman of the department of neurology at UF College of Medicine and the national medical director for the National Parkinson Foundation. “The Infinity DBS system has a newly designed DBS lead with segmented contacts, which can be used to tailor the DBS therapy approach for an individual patient and to optimize benefits while reducing common DBS-related side effects.”
The St. Jude Medical Infinity system also offers new, distinct patient advantages such as being the world’s first and only DBS system operating on a wireless iOS software platform. The system uses a clinician programmer with an iPad mini™ mobile digital device and an iPod touch™ mobile digital device patient controller with Bluetooth® LE connectivity that can expedite the programming process for the neurologist, while offering patients a discreet experience. Conveniently, the system battery is available in two different sizes to accommodate different body types and offers a maintenance-free, long-lasting recharge-free option for DBS therapy.
“The St. Jude Medical Infinity DBS system and directional lead represent St. Jude Medical’s commitment to the treatment of debilitating movement disorders,” said Dr. Allen Burton, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “The new St. Jude Medical Infinity system was designed to streamline therapy programming, allowing physicians more time to provide care to more patients. The system was also designed to provide patients with the best possible experience to manage their symptoms in a discreet manner that fits more easily into their lives.”
For more information about St. Jude Medical’s focus on the treatment of movement disorders, visit the patient website at www.sjm.com/DBS.
Note: Apple, iPod touch and iPad mini are trademarks of Apple, Inc. Bluetooth is a registered trademark of Bluetooth SIG, Inc., iOS is a trademark of Cisco Technology, Inc.
About St. Jude Medical
St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.
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, reimbursement strategies, 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 January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 2, 2016. The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.