Medtronic commences Embrace clinical trial of SynchroMed II

Medtronic’s Embrace TDD clinical trial will assess the efficacy of SynchroMed II intrathecal drug delivery system which is being positioned as a possible alternative to oral opioids for patients with chronic intractable non-malignant primary back pain with or without leg pain. The trial will involve approximately 100 patients, and will track those who wean completely off all oral opioids and have a successful intrathecal drug trial.
SynchroMed II pain pump and catheter are placed under the skin and deliver medication into the intrathecal space, providing better pain relief at a fraction of the oral dose with less side effects, and can be used with Medtronic’s Control WorkflowSM to help wean patients off oral opioids and identify appropriate patients for the pain pump. Control WorkflowSM comes with guidance on therapy initiation and catheter placement and dosing.
Medtronic’s Charlie Covert said: “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. We hope the Embrace TDD study will provide valuable insights about how to best optimize use of the Medtronic pain pump and enable clinicians to help more patients with chronic pain, which has a significant personal and societal impact.”