St. Jude’s Infinity Deep Brain Stimulation System receives CE mark

St. Jude Medical Infinity DBS system

St. Jude Medical has received European CE Mark approval to introduce its Infinity deep brain stimulation (DBS) implant and matching directional DBS lead for people suffering from Parkinson’s, tremor, and dystonia. The Bluetooth-enabled system comes with Apple iPod Touch controllers to allow patients to turn the device on and off, and change modes, while physicians use iPad Minis for programming the implants during office visits.

The new directional leads promise greater control of how electric pulses are delivered to the brain, helping to steer around potential side effects and eventually leading to more effective therapy. Moreover, the software is upgradeable, enabling the addition of new stimulation modes that will be coming out in the future. Any such upgrade can be done wirelessly, without requiring surgery to upgrade the device.

The system comes with Apple iPod Touch controllers for patients, while physicians use iPad Minis for programming the implants during office visits.“The Infinity DBS system, including our directional lead and wireless technology, represents a major step forward in our DBS product portfolio, demonstrating St. Jude Medical’s commitment to patient-centric solutions to help alleviate the debilitating effects of movement disorders,” said Eric Fain, M.D., group president at St. Jude Medical. “Not only are we able to offer therapy solutions for a broad set of indications for movement disorders, but we’ve also designed the system to provide patients the best possible experience with their therapy while helping physicians manage their patients more efficiently and effectively.”

The Infinity DBS system comes in two sizes to better match patient needs and has an improved non-rechargeable maintenance-free battery.

St. Jude Medical’s other offering Invisible Trial System, made for chronic pain patients to better assess spinal cord stimulation therapy prior to permanent implant, has been cleared earlier this year by both European and U.S. regulatory bodies.