Medical device firm St. Jude Medical has received CE mark approval for its new Invisible Trial System, which is an app-based and wireless neuromodulation programming system.


Employing Apple and Bluetooth wireless technology, the new system is said to provide a secure, safe and wireless experience when patients trial spinal cord stimulation to treat chronic pain prior to permanent implant.

St. Jude Medical group president Dr Eric Fain said: "We’ve developed our new patient-centric Invisible Trial System as a response to physician and patient feedback.

"The system was designed to improve the comfort and usability of our system for patients evaluating spinal cord stimulation therapy to alleviate their chronic pain without focusing on potential barriers such as programming trial cables and systems with complex trial controls."

Leveraging Apple iPod touch and iPad mini technology, the system uses an external pulse generator (EPG) as its power source. The EPG applies Bluetooth communication to communicate between the patient’s iPod touch controller and the stimulation system.

The physician can use the iPad mini tablet to set the programming parameters. The programmer displays trial usage data from the EPG, allowing physician to print or email the data in PDF format.

Bluetooth technology safely and securely communicates wirelessly between the EPG and patient and physician devices, reducing the programming trial cable.

The system also has the capacity to deliver both traditional and burst stimulation modes. Burst stimulation was shown to minimize paresthesia in most patients.

Image: The new Invisible Trial System allows patients to focus more on potential pain relief and therapeutic impact during their spinal cord stimulation trial period. Photo: courtesy of St. Jude Medical, Inc.