FDA approves St Jude Medical’s Invisible Trial system

16 July 2015 (Last Updated July 16th, 2015 18:30)

St Jude Medical has received approval from US Food and Drug Administration (FDA) for its Invisible Trial system, which offers an improved and discreet spinal cord stimulation (SCS) trial experience to patients.

Invisible Trial System

St Jude Medical has received approval from US Food and Drug Administration (FDA) for its Invisible Trial system, which offers an improved and discreet spinal cord stimulation (SCS) trial experience to patients.

Leveraging Bluetooth wireless technology and Apple digital devices, the system is designed to help chronic pain patients better assess SCS therapy prior to a permanent implant.

The SCS therapy uses a small implanted device and thin wires to supply 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.

"By providing a discreet trial system, St Jude Medical will help patients focus more on their potential pain relief and functional improvements."

Patients undergo a minimally invasive 'trial' period to test the therapy before receiving a permanently implanted SCS device. Complex controllers and bulky programming cables can disrupt the trial experience and act as barrier to therapy in some individuals.

The Invisible Trial system provides patients with an intuitive iPod touch digital device as a controller, while physicians will use an iPad mini digital device to programme and evaluate their patient's therapy.

Summit Pain Alliance president Dr Jason Pope said: "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.

"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 system can be worn discreetly under a patient's clothing as it uses a small external pulse generator (EPG) as the power source, which in turn uses Bluetooth wireless technology to communicate with the patient's iPod touch controller.

The iPod touch controller enables patients to adjust their therapy, while 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 enables the physician to print or email the data in PDF format. The system received CE Mark approval in June.


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