FDA approves Proclaim Elite SCS System


St Jude Medical has announced FDA approval of the new Proclaim Elite Spinal Cord Stimulation System, the first and only upgradeable and recharge-free spinal cord stimulation (SCS) system available to people in the USA suffering from chronic pain. The approval also includes conditional magnetic resonance (MR) labelling for the Proclaim Elite SCS system, which will allow patients to safely undergo head and extremity MRI scans.

The current approval also includes the company’s new, innovative clinician programmer, which allows clinicians to programme 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 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, president and chief executive officer of The Center for Pain Relief in Charleston, West Virginia, USA. “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.”

St Jude Medical designed many elements of the Proclaim system based on 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. Historically, most patients would need additional surgery to receive product upgrades as they are approved.