FDA approves St. Jude Medical’s Proclaim Elite SCS system

19 November 2015 (Last Updated November 19th, 2015 18:30)

The US Food and Drug Administration (FDA) has granted approval for St. Jude Medical's new Proclaim Elite spinal cord stimulation (SCS) system.

The US Food and Drug Administration (FDA) has granted approval for St. Jude Medical's new Proclaim Elite spinal cord stimulation (SCS) system.

Proclaim Elite is claimed to be the first and only upgradeable and recharge-free SCS system available for the treatment of chronic pain in the US.

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

"This pioneering platform can improve both the patient's chronic pain and overall therapy experience."

The upgradable platform of the system helps patients to access future SCS technology upgrades, such as new stimulation waveforms and software updates, without surgical device replacement.

Approval was also granted for the company's new clinician programmer that will enable clinicians to programme and adjust their patient's SCS therapy with an Apple iPad Mini.

St. Jude Medical neuromodulation medical director Dr Allen Burton said: "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."

With the the company's Invisible Trial System, a discreet, app-based and wireless neuromodulation programming system, patients will also be able to evaluate spinal cord stimulation.

In July, the company secured FDA approval for its Invisible Trial System, which is designed to provide a secure, safe and wireless experience when patients trial SCS to treat chronic pain prior to permanent implantation.

The system uses small external pulse generator (EPG) as its power source, while EPG utilises Bluetooth wireless technology to communicate between the patient's iPod touch controller and the stimulation system.