The Journal of mHealth Vol 2 Issue 4 (August) - Page 10

INDUSTRY NEWS News and Information for Digital Health Professionals FDA Approves iOS-based Spinal Cord Stimulation Trial System the treatment will work for them with no invasive surgery. “By providing a more patientfriendly 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.” St. Jude medical has announced that its new wireless spinal cord stimulation trial system has been approved by the FDA. The system, which received a CE Mark in June 2015, is a fully wireless system designed to provide patients a more improved and discreet spinal cord stimulation (SCS) trial experience. 8 The device allows patients to test out spinal cord stimulation treatment before having a permanent device implanted in their back. This helps determine if August 2015 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 fibres to the brain, which reduces the sensation of pain. Prior to receiving a permanently implanted SCS device, patients undergo a minimally in vasive “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. With the Invisible Trial System, St. Jude Medical has removed these barriers, allowing patients to more effectively eval- uate 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 St. Jude Medical Invisible Trial System provides patients with a more intuitive iPod touch digital device as a controller, while physicians will utilise 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 Dr. Jason E. Pope, 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 St. Jude Medical 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 over-