St. Jude Medical wins FDA approval for Proclaim Elite spinal cord stim device

St. Jude Medical (NYSE:STJ) said today that it won FDA approval for its Proclaim Elite spinal cord stimulation device for treating chronic pain.

Little Canada, Minn.-based St. Jude claimed the device as the sole U.S.-approved upgradable and recharge-free SCS system, noting that the federal safety watchdog also approved conditional MR labeling for the Proclaim Elite for head and extremity scans.

The device can be fine-tuned via Bluetooth by doctors using Apple‘s (NSDQ:AAPL) iPad mini tablet, St. Jude said. Patients can try out SCS treatment using its “invisible trial system” on iPad touch devices, the company said.

“St. Jude Medical has a legacy of consistently advancing spinal cord stimulation therapy options to our ensure chronic pain patients are receiving innovative, patient-centric devices and optimal therapy to manage their chronic pain,” neuromodulation medical director Dr. Allen Burton said in prepared remarks. “The new St. Jude Medical Proclaim Elite system bridges the gap between today’s state-of-the-art therapies and tomorrow’s groundbreaking innovations for chronic pain. The wireless platform is based on the latest Apple technologies making it upgradeable to new therapies for the future. With a discreet, hassle-free trial system and a simple permanent implant procedure, this pioneering platform can improve both the patient’s chronic pain and overall therapy experience.”

“The approval of the Proclaim Elite recharge-free SCS system is a needed advancement for both patients and physicians who now have access to a low-maintenance chronic pain treatment that can reduce interference with daily activities,” added Dr. Timothy Deer, of Charleston, W.Va.’s Center for Pain Relief. “In the last 10 years of SCS, we have seen advances in rechargeable technology but less attention paid to therapy compliance and how patients interact with their device. Now with the Proclaim Elite SCS system we can offer appropriate patients an optimal low-maintenance experience while enabling access to future therapies without the need for additional surgeries.”

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