FDA gives its first nod to St. Jude for an Apple-compatible device to try out pain neurostim implant

Invisible Trial System--Courtesy of St. Jude Medical

The U.S. Food and Drug Administration may have made it a bit easier for chronic pain patients to evaluate whether a spinal cord stimulator could be an effective treatment. For the first time, it's approved a wireless, external device from St. Jude Medical ($STJ) that can be manipulated via an Apple iPod touch, rather than a dedicated controller that's likely to be less intuitive to patients.

Called the St. Jude Medical Invisible Trial System, it is designed to be programmed and tracked by a physician using an iPad mini device. Data is transmitted wirelessly via Bluetooth between the small external pulse generator (EPG), the patient iPod controller and the physician iPad mini that comprise the system. A physician can download and analyze patient usage data via the iPad mini.

"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," pain specialist Dr. Jason Pope, president of Summit Pain Alliance in Santa Rosa, CA said in a statement.

He added, "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."

The EPG device is smaller than it was previously and can be worn under the patient's clothing. The intent is to make it less obtrusive and more similar to a post-implant experience. The Invisible Trial System gained a CE mark in June.

"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 St. Jude Group President Dr. Eric Fain in a statement. "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."

- here is the release

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