![]() ![]() I can take long walks and experience things with my friends. When he had pain relief during the trial period, he decided to have the device implantation.Īnd now? "The device has given me enough freedom to where I now go back out and do things. "It allowed me to record my responses to different stimuli, which was helpful information for my doctor," Robert noted. He used Abbott’s NeuroSphere™ myPath™ app during the trial period. Robert underwent a temporary trial implant. Then Robert’s pain doctors suggested Abbott's Proclaim™ XR SCS therapy. But I kept getting worse," Robert explained. "We tried opioids, different physical therapies, some electrostimulation devices, acupuncture and more. Relief with a trial period, then an SCS implantation They also interfered with my ability to think and articulate clearly, which made it tough to do my job." "We tried so many different medications, but they were not very effective. ![]() And emotionally, that was incredibly difficult to deal with," said Robert. I likewise couldn't sleep because my leg felt like it was being crushed in a vise, and every step I took felt like a hammer hitting my leg.”Īs the pain progressed “I wasn't able to function as a Marine, a lawyer, or even a husband and father because I couldn't do things we would normally do as a family. He couldn’t even take a bath because “any contact with the water, regardless of temperature, felt like daggers. "Immediately after the operation, I had very intense pain,” said Robert. After another surgery he suffered severe peripheral nerve damage. The heavy packs, long hikes, and extensive running began to take their toll on his previously injured leg, and Robert broke his ankle. ![]() But he did not give up on his dream of being a Marine, going on active duty in 2015. And that's a terrifying thing as a young father.Īfter breaking his leg in three places, having surgery, and being deemed not physically qualified to continue with Marine Officer Training School at the time, Robert focused on a law degree. He realized that he "could not take care of her by myself. "I think the saddest moment was when I realized I couldn't pick up my two-year-old daughter,” said Robert, a Marine officer and lawyer who was not accustomed to feeling vulnerable. Data from the Medicare database showed that despite increased numbers of implant site infections or other adverse events for people with diabetes, the level of risk remained acceptable for this group.Robert: From constant, severe pain to now carrying his daughter on his shoulders Patients reported an average pain relief of 53%, measured using questionnaires, which was maintained for over 5 years at clinically meaningful levels (≥ 50% pain relief). What will it accomplish?ĭata from published research studies support the effectiveness of Abbott’s Prodigy, Proclaim, and Proclaim XR SCS Systems when treating people with chronic, intractable pain of the trunk and/or limbs caused by diabetic peripheral neuropathy of the lower extremities. When is it used?Ībbott’s Prodigy, Proclaim, and Proclaim XR SCS Systems are used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided or two-sided pain associated with the following: failed back surgery syndrome, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities. Doctors believe stimulation targets specific nerves that impact how pain is perceived and/or nerve structures that aren’t working properly. The signals tell the IPG when to deliver appropriate stimulation to the spinal cord. The implanted pulse generator (IPG) receives radio signals from the patient controller. This supplement expands the Indications for Use to include treatment of diabetic peripheral neuropathy of the lower extremities through a series of consistent stimulation pulses, called the tonic stimulation mode. The main components of these SCS systems are an implanted pulse (signal) generator that is connected to one or two implanted leads, a patient controller, and a clinician programmer. Product Name: Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) SystemsĪddress: 6901 Preston Road, Plano, TX 75024 USAĪpproval Letter: Approval Order What is it?Ībbott’s Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems are implanted spinal cord stimulation systems intended to treat long-term (chronic) pain in the trunk or limbs that is difficult to manage (intractable). See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. This is a brief overview of information related to FDA’s approval to market this product. ![]()
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