St Jude Medical launches spinal cord stimulation system in Europe


St Jude Medical has launched its Proclaim Elite spinal cord stimulation (SCS) system in Europe. According to a press release, this is the world’s first upgradeable, non-rechargeable SCS system, which is approved to deliver burst-stimulation, and to use conditional magnetic resonance (MR) in order to allow patients to undergo head and extremity MRI scans safely.

The non-rechargeable system is designed to remove the burden of regularly recharging the SCS system from patients. The device’s patient controller and clinician programmer are Bluetooth-enabled, and leverage Apple mobile digital devices, designed to allow for effective management of the chronic pain treatment.

By providing access to both traditional SCS and burst stimulation from St. Jude system, the device can improve patient outcomes and provide options for patients who either didn’t initially respond to traditional SCS therapy or those who might lose pain relief over time, according to a press release. The Proclaim Elite SCS system is also upgradeable, to allow easy access to future therapy and software advances as they are approved in the future.

“We developed the Proclaim Elite SCS system to create a more patient-centric spinal cord stimulation therapy option,” says Allen Burton, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical.

The novel upgradeable platform of the Proclaim Elite SCS system should allow patients to access future SCS technology upgrades without surgical device replacement.

“With the Proclaim system, we’re seeing a shift in the SCS treatment paradigm as we move to a device that’s capable of delivering effective therapy tailored to a patient’s pain condition but that requires no device recharging,” says Frank Huygen, an anaesthesiologist and pain specialist from Erasmus MC Hospital, Netherlands. “This technology ensures physicians are more empowered to deliver therapy that can appropriately address our patients’ pain, while keeping them on the forefront of therapy advancements as they are approved and securing access to MRI head and extremity scans if needed.”

The proprietary burst stimulation developed by St. Jude Medical works by utilising intermittent “burst” pulses designed to mimic the body’s natural nerve firing patterns and provide a more physiologic therapy method for chronic pain conditions. St. Jude Medical is the only company approved to offer patients burst stimulation, which was introduced after nearly a decade of research and study in collaboration with Dirk De Ridder, who filed the therapy’s initial patents in 2005. St. Jude Medical will present the results of the SUNBURST US IDE study evaluating burst stimulation during the upcoming 19th annual meeting of the North American Neuromodulation Society (NANS) in Las Vegas, Nevada. The SUNBURST study is designed to support approval of burst stimulation in the USA.