![]() ![]() Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. The following warnings apply to this neurostimulation system. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met.įor more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at medical.abbott/manuals).įor more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Indications For UseĪbbott Medical spinal cord stimulation (SCS) systems are indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, nonsurgical back pain (without prior surgery and not a candidate for back surgery), and diabetic peripheral neuropathy of the lower extremities. The system is intended to be used with leads and associated extensions that are compatible with the system. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Once in place, their electrical pulses are meant to block pain signals from reaching the brain.īefore securing FDA approval, the technology was put to the test in its new indication in a study of 270 patients with an average of more than 12 years of pain-constituting what the company has dubbed the largest randomized, controlled trial for SCS in people with nonsurgical back pain.Īmong the first 200 participants in the trial, about 85% of those who were implanted with the Proclaim XR system achieved “significant back pain reduction,” according to Abbott, compared to just 7% of those in the control arm, who were treated with a “conservative medical management” approach comprising physical therapy, medications, massages, acupuncture and more.Īltogether, more than 90% of those who underwent SCS treatment reported significant pain relief or improvements in function, with an average pain reduction of nearly 70%.Spinal Column Stimulation (SCS) Systems Intended Use It sends out short bursts of low-dose electrical energy rather than a continuous stream of stimulation, which Abbott says helps to avoid the uncomfortable tingling feeling that can sometimes occur with the latter “tonic” approach.īurstDR is used in all of Abbott’s SCS devices in the U.S., which center around pulse generators that are implanted under the skin of the lower back, where connected leads can be placed between the spine and vertebrae. Nevro nabs FDA approval for spinal cord stimulator that uses AI to personalize pain treatmentĪbbott’s BurstDR technology is designed to be a closer mimic of the nervous system’s natural rhythm than other SCS approaches.
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