St. Jude Medical (NYSE:STJ) said today that it won approval from the FDA for its Invisible Trial app for testing its spinal cord stimulation devices.
The wireless neuromodulation system uses Apple (NSDQ:AAPL) iOS devices, specifically an iPod touch for the patient and an iPad mini for the treating physician, and an external pulse generator that connects the stimulator and the Apple device via Bluetooth, St. Jude said. The system is able to deliver both traditional and burst stimulation modes, which have been shown to reduce paresthesia.
The Invisible Trial app won CE Mark approval in the European Union last month. The system, which can be worn under clothing, is designed to make it easier for patients to test-drive their SCS therapy, St. Jude said.
“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,” group president Dr. Eric Fain said in prepared remarks. “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.”
“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,” added pain specialist Dr. Jason Pope 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.”
