Compelo Medical Devices - Latest industry news and analysis is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More
Close
Dismiss

St. Jude Medical obtains FDA approval for Invisible Trial System

Medical device firm St. Jude Medical has received approval from the US Food and Drug Administration (FDA) for its Invisible Trial System.

Apple

The app-based and wireless neuromodulation programming system also obtained CE mark approval last month.

Employing Apple iPod touch and iPad mini technology, the new system will provide a secure, safe, and wireless experience when patients trial spinal cord stimulation (SCS) to treat chronic pain prior to permanent implantation.

St. Jude Medical group president Dr Eric Fain 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.

"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 system uses small external pulse generator (EPG) as its power source, while EPG utilises Bluetooth wireless technology to communicate between the patient’s iPod touch controller and the stimulation system.

The iPod touch controller is said to provide simple platform for patients to adjust their therapy and iPad mini tablet enables patient’s physician to set the programming parameters.

In addition, the programmer shows trial usage data from the EPG and allows the physician to print or email the data in PDF format.


Image: The Invisible Trial System allows patients to more effectively evaluate their SCS therapy. Photo: courtesy of Business Wire.