FDA OKs St. Jude's MRI-compatible spinal cord stimulation system

FDA sign

Just one week after bagging a CE mark for its MRI-compatible CRT pacemaker, St. Jude Medical announced an FDA full-body MRI label for its recharge-free spinal cord stimulation system.

This is the second major update to St. Jude’s Proclaim Elite Spinal Cord Stimulation System, which was approved in November 2015. It is indicated for the treatment of chronic back pain and frees the patient from needing to regularly charge the device. The device is based on an upgradeable platform, allowing patients to receive new features, such as the newly approved “burst” stimulation, without requiring additional surgeries.

The implant is placed under the skin to deliver neurostimulation to a patient’s spinal cord. The patient uses an iPod Touch to control the stimulation via Bluetooth. In October this year, St. Jude unveiled its BurstDR system to be used with the Proclaim Elite system. The “burst” technology contrasts with traditional SCS in that it delivers “burst” pulses of stimulation that mimic the body’s natural nerve impulses.

The new approval for magnetic resonance condition labeling will allow patients with the implant to undergo full-body MRI. This would open up treatment options for patients who suffer from chronic pain, but were previously ineligible for the implant due to the need of diagnostic imaging in the future. St. Jude and Medtronic recently picked up a CE mark and FDA nod respectively for their MRI-compatible cardiac devices.

“Historically, the need for future MRI scans could act as a barrier to patients who may benefit from SCS therapy,” said Dr. Allen Burton, medical director of neuromodulation and vice president of medical affairs at St. Jude, in a statement. “Our new labeling for the Proclaim Elite SCS system ensures that patients can receive BurstDR stimulation while having the peace of mind knowing their SCS system can be safely scanned with diagnostic imaging.”