Little Canada, Minn.-based St. Jude said the MR-conditional label adds to the head and extremity CE Mark Proclaim Elite landed last year. The FDA cleared the system for full-body MRIs last month; St. Jude won FDA approval for the Proclaim Elite in November 2015, claiming it as the sole U.S.-approved upgradable and recharge-free SCS system.
The device uses St. Jude’s “BurstDr” technology, which is designed to reduce the sensation of tingling along the spinal cord called paresthesia that’s associated with tonic stimulation. The Proclaim Elite device can also be fine-tuned via Bluetooth by doctors using Apple’s (NSDQ:AAPL) mobile devices, which can also be used as the patient’s controller, St. Jude said.
“Historically, the need for future MRI scans could act as a barrier to patients who may benefit from SCS therapy,” medical affairs VP Dr. Allen Burton said in prepared remarks. “Our new labeling for the Proclaim Elite SCS system ensures that patients can receive the treatment they need, while having peace of mind knowing their SCS system can be safely scanned with the diagnostic imaging they require.”
“Providing patients with a multitude of therapy options in one device has positively impacted the way we treat chronic pain patients today,” added Dr. Dirk Rasche of Lübeck, Germany’s University Hospital of Schleswig-Holstein. “Patients now do not only have access to both traditional SCS and BurstDR stimulation, they can also safely undergo MRI scans, a significant improvement for future neuromodulation therapy and diagnostic options.”