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

By Aditi Pai
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Invisible_Trial_EPG_ipadSt. 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.

“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,” St. Jude Medical Group President Eric S. Fain said 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.”

St. Jude's system, an external pulse generator, is attached to the patient's back with adhesive and communicates with mobile devices via Bluetooth. Clinicians and patients use a clinician programmer app, available on the iPad mini, to create optimum stimulation programs. Patients also receive a controller app, which they can access on an iPod touch, so they can self-adjust the established program settings.

The physician's app will display trial usage data from the external pulse generator and allows the physician to print or email the data in PDF format.

The technology received a CE mark last month.

Last year, in June, St. Jude Medical acquired a digital health device maker, CardioMEMS, which received an FDA 510(k) clearance for its CardioMEMS HF System, which monitors pulmonary artery pressure.