FDA Approves St. Jude’s New User-Friendly Chronic Pain System

St. Jude Medical, Inc. has gained FDA approval for its new Proclaim™ Elite Spinal Cord Stimulation System, which it claims is the first and only upgradeable and recharge-free spinal cord stimulation (SCS) system available to people in the U.S. suffering from chronic pain.


Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. St. Jude Medical plays its part by developing innovative chronic pain therapeutic options. Its offerings include multiple solutions for patients to manage debilitating chronic pain, including spinal cord stimulation, spinal cord stimulation targeting the DRG and radiofrequency ablation

St. Jude’s Proclaim Elite SCS System focuses on patient convenience, comfort and pain relief to shift patient focus from their chronic pain therapy toward their quality of life. 

Many elements of the Proclaim system are a result of physician and patient feedback to ensure patients could benefit from all aspects of the product. In particular, the non-rechargeable system improves patient convenience by removing the burden of regularly recharging the SCS system. The system’s upgradable platform allows patients to access future SCS technology upgrades, such as new stimulation waveforms and software updates, without surgical device replacement.

Enhanced ease-of-use and familiarity for patients comes from leveraging Bluetooth® wireless technology and Apple™ mobile digital devices for the Proclaim Elite SCS system’s patient controller and clinician programmer. This approach will allow patients to interact with their device more easily, which can ensure effective management of their chronic pain treatment with minimal disruption to their daily life.

The current approval also includes the company’s new, innovative clinician programmer, which allows clinicians to program and adjust their patient’s spinal cord stimulation therapy with an Apple™ iPad mini™ mobile digital device. In addition, patients will be able to evaluate spinal cord stimulation with the St. Jude Medical™ Invisible Trial System, a discreet, app-based and wireless neuromodulation programming system leveraging Apple™ iPad touch™ mobile digital devices.

The approval also includes conditional magnetic resonance (MR) labeling for the Proclaim Elite SCS system, which will allow patients to safely undergo head and extremity MRI scans.

Physician comments

“The approval of the Proclaim Elite recharge-free SCS system is a needed advancement for both patients and physicians who now have access to a low-maintenance chronic pain treatment that can reduce interference with daily activities,” said Timothy R Deer, M.D., president and chief executive officer of The Center for Pain Relief in Charleston, West Virginia. “In the last 10 years of SCS, we have seen advances in rechargeable technology but less attention paid to therapy compliance and how patients interact with their device. Now with the Proclaim Elite SCS system we can offer appropriate patients an optimal low-maintenance experience while enabling access to future therapies without the need for additional surgeries.”

Company comments

“St. Jude Medical has a legacy of consistently advancing spinal cord stimulation therapy options to our ensure chronic pain patients are receiving innovative, patient-centric devices and optimal therapy to manage their chronic pain,” said Allen Burton, M.D., medical director of neuromodulation at St. Jude Medical. “The new St. Jude Medical Proclaim Elite system bridges the gap between today’s state-of-the-art therapies and tomorrow’s groundbreaking innovations for chronic pain. The wireless platform is based on the latest Apple technologies making it upgradeable to new therapies for the future. With a discreet, hassle-free trial system and a simple permanent implant procedure, this pioneering platform can improve both the patient’s chronic pain and overall therapy experience.”

Source: Business Wire


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