FDA Approves St. Jude Medical Invisible Trial System

St. Paul. Minn.-based St. Jude Medical Inc., has earned U.S. Food and Drug Administration approval for its Invisible Trial System. The system, which received CE mark in June 2015, is fully wireless and leverages Apple technology for both the patient and physician controllers. The system is designed to provide patients a more improved and discreet spinal cord stimulation (SCS) trial experience.

For many patients, SCS therapy can be an effective option for managing chronic pain. The therapy relies on a small implanted device and thin wires (known as leads) to deliver low levels of electrical energy to mask or interrupt pain signals as they travel along nerve fibers to the brain, which reduces the sensation of pain. Prior to receiving a permanently implanted SCS device, patients undergo a minimally invasive “trial” period to evaluate the therapy. Yet for some patients, complex controllers and bulky programming cables can disrupt the trial experience and act as barrier to SCS therapy.

According to St. Jude Medical, the Invisible Trial System removes these barriers, allowing patients to more effectively evaluate their SCS therapy. The system relies on Bluetooth wireless technology to provide patients a safe, secure and entirely wireless SCS trial experience. Rather than a complex controller, the system provides patients with a more intuitive iPod touch digital device as a controller, while physicians will use an iPad mini digital device to program and evaluate their patient’s therapy.

“Patients undergoing SCS trials consistently tell us about challenges they find in navigating the SCS trial system, from programming the device, to discomfort from the programming cables, to management of both issues. These hindrances may impede the integration of the technology into their daily activities, which shifts their focus away from evaluating the effectiveness of SCS therapy,” said pain specialist Jason E. Pope, M.D., president of Summit Pain Alliance in Santa Rosa, Calif. “By providing a discreet trial system, St. Jude Medical will help patients focus more on their potential pain relief and functional improvements, and less about the burdens common to traditional trial systems.”

One of the key system features of the Invisible Trial System is the use of a small external pulse generator (EPG) as the system’s power source. Because the EPG uses Bluetooth wireless technology to communicate between the patient’s iPod touch controller and the stimulation system, the overall device profile has been reduced so the system can be worn discreetly under a patient’s clothing. The effect is that the system feels essentially “invisible” to the wearer, providing a more comfortable trial experience that allows patients to focus entirely on their system’s therapeutic impact during their trial.

“When we developed the new Invisible Trial System, we took into account physician and patient feedback that current trial systems were in some cases preventing patients from adequately assessing their therapy,” said Eric S. Fain, M.D., group president of St. Jude Medical. “By providing a more patient-friendly option, we think we can shorten the learning curve related to trial programming devices and allow patients to better assess the potential pain relief they’re receiving from spinal cord stimulation.”

The iPod touch controller offers patients a simple, familiar platform to adjust their therapy. An iPad mini tablet is used by the patient’s physician to set the programming parameters. The programmer also displays trial usage data from the EPG and allows the physician to print or email the data in PDF format. Bluetooth wireless technology safely and securely communicates wirelessly between the EPG and patient and physician devices, eliminating the programming trial cable and thus, it is hoped, increasing the patient’s comfort.