The 100-patient Embrace TDD study is slated to follow patients who have weaned off all oral opioids, in the hopes of positioning the SynchroMed II pump as a viable alternative for people with chronic intractable non-malignant primary back pain.
Medtronic said the study will evaluate pain control and opioid-related side effects at six months. The trial’s researchers plan to follow patients for one year.
“There are several strategies to approach weaning prior to or following TDD treatment. The Embrace TDD study is important because it will evaluate the impact of weaning patients completely off oral opioids before treating them with intrathecal therapy using the Medtronic pain pump,” Dr. John Hatheway, owner and provider at Northwest Pain Care, said in prepared remarks.
“My goal is to provide patients with effective pain relief and help them eliminate long-term oral opioid use. Understanding the effect of being opioid free prior to TDD treatment may be clinically relevant as clinicians seek to optimize the use of long-term alternatives to oral opioids,” Hatheway added.
“As part of our commitment to helping address the opioid crisis, Medtronic is investing in clinical research and tools that can increase understanding of how to use proven alternative treatments, like TDD, for patients with uncontrolled chronic pain,” Charlie Covert, VP & GM of Medtronic’s targeted drug delivery unit, said.
In January last year, the FDA approved a new clinician application for Medtronic’s SynchroMed II pump. The programmer includes a side-by-side comparison of therapy changes and dosing graphics, as well the ability to communicate wirelessly with the pump.
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