US-based medical device manufacturer St. Jude Medical has received approval from the US Food and Drug Administration (FDA) for its Infinity Deep Brain Stimulator (DBS), a device for the treatment of tremors associated with Parkinson’s Disease, and which can be controlled using an Apple phone or tablet, the company announced in a press release.
The device uses electrical current to stimulate areas of the brain to counteract the tremors caused by the deterioration of the nervous system that is characteristic of Parkinson’s.
The Infinity device, St. Jude Medical said, has two essential features that are firsts for FDA approval. The first is the use of “directional leads,” which allow doctors to “steer” current to different parts of the brain, tailoring treatment to reduce side effects.
The second feature is that the system is designed so that Apple mobile devices can be used as wireless controllers, via a Bluetooth connection; St. Jude claims the system as the only upgradeable DBS platform for movement disorders. Patients using the Infinity system can link it to Apple’s iPod Touch; physicians can program the device using the Apple iPad Mini, according to the company.
Dr. Kelly Foote of the University of Florida Center for Movement Disorders & Neurorestoration performed the first Infinity implantation in the US at the UF Health Shands Hospital, St. Jude 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,” Foote said in remarks included in the company press statement.
“The St. Jude Medical Infinity DBS system and directional lead represent St. Jude Medical’s commitment to the treatment of debilitating movement disorders,” added St. Jude neuromodulation medical director Dr. Allen Burton. “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.”
The Infinity system with its directional leads was approved in June for use in Europe, after winning CE Mark approval in the European Union in September 2015, the company said.
St. Jude said the device is currently available in ‘select’ international markets, with more countries expected to approve the system next year.