St. Jude Medical Receives FDA Approval For The Industry's First SCS Trial System

(RTTNews) - St. Jude Medical, Inc. (STJ), a global medical device company, announced FDA approval of the St. Jude Medical Invisible Trial System. The system, which received CE Mark in June 2015, is fully wireless and leverages Apple technology for both the patient and physician controllers.

The company said the system is designed to provide patients a more improved and discreet spinal cord stimulation or SCS trial experience.

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 to deliver low levels of electrical energy to mask or interrupt pain signals as they travel along nerve fibers to the brain, which reduces the sensation of pain.

Prior to receiving a permanently implanted SCS device, patients undergo a minimally invasive "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 evaluate 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 utilize an iPad mini digital device to program and evaluate their patient's therapy, the company stated.

One of the key system features of the St. Jude Medical Invisible Trial System is the use of a small external pulse generator or EPG as the system's power source.