St. Jude Medical receives CE mark for its wireless neuromodulation trial system

Invisible Trial System

St. Jude Medical scored CE Mark approval for its Invisible Trial System, an app-based and wireless neuromodulation programming system for trial spinal cord stimulation for the treatment of chronic pain prior to permanent implantation. The setup involves an iPad or iPod Touch, and a small device that can be worn under a patient’s clothing, often rendering the entire system “invisible.” It is made to help patients focus more on potential pain relief and therapeutic impact during their trial and less on the trial system itself.

The Invisible Trial System uses an external pulse generator (EPG) for its power source and Bluetooth to communicate between the patient’s mobile device and the stimulation system. It also supports both traditional and Burst stimulation modes. Burst stimulation has been demonstrated to minimize paresthesia in most patients. Paresthesia is a sensation which can often fluctuate with posture and body position changes and negatively impact the trial experience.

“We’ve developed our new patient-centric Invisible Trial System as a response to physician and patient feedback,” said Eric S. Fain, M.D., group president of St. Jude Medical. “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.”

Chronic pain affects one in five adults across Europe and more than 1.5 billion people worldwide. Spinal cord stimulation (also known as neurostimulation or SCS) therapy is a proven therapy for managing chronic pain. SCS uses a small implanted medical device and thin wires or leads with electrodes, placed in the epidural space near the spine, to deliver low levels of electrical energy to nerve fibers. These electrical pulses mask or interrupt pain signals as they travel to the brain, reducing pain sensation. Before receiving the permanent implanted device, patient’s candidates can evaluate the therapy by having a minimally invasive procedure used to place the lead, which is connected to an external power source.