|Proclaim Elite Spinal Cord Stimulation System--Courtesy of St. Jude Medical|
St. Jude Medical ($STJ) announced FDA approval of the Proclaim Elite Spinal Cord Stimulation System to treat chronic back pain.
It's the only recharge-free spinal cord stimulation system in its class, at least in the U.S., the company says in a release.
In addition, the approval covers St. Jude's clinician programmer for the adjustment of stimulation therapy using an Apple iPad mini. And patients can evaluate the therapy using St. Jude's Invisible Trial System, an app for wireless neuromodulation programming that runs on the Apple iPod touch, St. Jude said in a release.
"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," said Dr. Timothy Deer, CEO of the Center for Pain Relief in Charleston, WV, in a statement. "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."
St. Jude earned $121 million in neuromodulation revenues in Q3 2015, a 19% year-over-year increase on a constant currency basis.
The company says chronic pain affects 1.5 billion people across the world.
- read the release