St. Jude receives FDA 510(k) clearance for mobile-enabled spinal cord stimulation trial system

By Aditi Pai

St. Jude Medical has announced that it received FDA 510(k) clearance for the St. Jude Medical Invisible Trial System, which is a mobile-enabled discreet spinal cord stimulation (SCS) trial system.

Patients who need spinal cord stimulation therapy, which helps them manage chronic pain, can have small device implanted in their body. The implant connects to thin wires, called leads, which deliver low levels of electrical energy to mask or interrupt pain signals. This reduces the sensation of pain for the patient.

But, before receiving a permanently implanted SCS device, patients are first given a minimally invasive trial device to evaluate the therapy. This trial device, though, is often connected to controllers and bulky programming cables, which can disrupt the trial experience and may be a barrier to SCS therapy.


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