EU Launch of St. Jude’s Burst-Enabled MR-Conditional SCS System

Device giant, St. Jude Medical, Inc. has announced the European launch of the Proclaim™ Elite Spinal Cord Stimulation (SCS) System.


According to the International Neuromodulation Society, nearly 95 million people in Europe suffer from chronic pain, a serious condition that can negatively impact a patient’s personal relationships, work productivity and quality of life. Traditional tonic SCS therapy has been proven to offer meaningful chronic pain relief for many patients, but some patients do not respond to tonic SCS therapy or can see a reduced benefit from the therapy over time.

Directly targeting this problem, St. Jude’s proprietary so-called burst stimulation utilizes 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, M.D., Ph.D., who filed the therapy’s initial patents in 2005.

In addition to improved pain relief, in most patients, burst stimulation has been demonstrated to significantly reduce or eliminate paresthesia, the tingling sensation commonly associated with traditional SCS. By offering both stimulation waveforms in both rechargeable and non-rechargeable devices, St. Jude Medical provides patients a range of therapeutic options.

As well as being the first and only upgradeable and non-rechargeable SCS system approved to deliver burst stimulation, conditional magnetic resonance (MR) is also included on the labeling, which will allow patients to safely undergo head and extremity MRI scans.

The novel upgradeable platform of the Proclaim Elite SCS system allows patients to access future SCS technology upgrades without surgical device replacement. Historically, most patients would need additional surgery to receive new product features and benefits.

Company comments

“We developed the Proclaim Elite SCS system to create a more patient-centric spinal cord stimulation therapy option,” said Allen Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “With the launch of this device we are transforming the standard of care by packaging a series of important benefits into a single SCS device. The Proclaim Elite SCS system offers patients a combination of advanced pain therapy options and the convenience of a device that doesn’t require recharging, while removing barriers for future therapy and diagnostic options.”

“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,” said Frank Huygen, M.D., Ph.D., an anesthesiologist and pain specialist from Erasmus MC Hospital in the Netherlands. “By combining burst stimulation and upgradeability in a non-rechargeable device, this innovative 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.”

Source: Business Wire

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