Medtronic plc announced the first patient enrolled in the Embrace TDD (targeted drug delivery) clinical study that will evaluate the use of the SynchroMed(TM) II intrathecal drug delivery system as an alternative to oral opioids for patients with chronic intractable non-malignant primary back pain with or without leg pain. The Medtronic pain pump provides effective pain relief at a fraction of the oral dose with fewer side effects and may help reduce or eliminate the use of oral opioids. The Embrace TDD study will follow patients who wean completely from all oral opioids and have a successful intrathecal drug trial. The first patient was enrolled by John A. Hatheway, M.D., in Spokane, Wash. Oral opioids are widely used to treat pain; however, there is limited evidence on the effectiveness and benefits of long-term oral opioid therapy. Given the current opioid epidemic and ongoing pain management crisis, there is a need to better understand solutions that effectively address chronic pain and support the elimination of oral opioids. There is evidence that oral opioid tapering and elimination may improve pain relief and allow for treatment with a lower effective dose of intrathecal medication compared to a combination of oral and intrathecal treatment. The Embrace TDD study was designed to further understand the impact of an opioid-free period prior to TDD treatment on patient outcomes. The Embrace TDD study is a prospective, multi-center, post-market study that will enroll approximately 100 patients with chronic intractable non-malignant primary back pain with or without leg pain at up to 15 sites in the U.S. Patients will wean from all oral opioids prior to initiating intrathecal therapy. The study will assess pain control and opioid-related side effects at six months following a route of delivery change to intrathecal preservative-free morphine sulfate. Patients taking a daily systemic opioid dose of <= 120 Morphine Milligram Equivalents (MME), who are candidates for TDD, are eligible. Patients will be followed for 12 months. The Medtronic pain pump and catheter are implanted under the skin and deliver medication into the intrathecal space, enabling clinicians to prescribe reduced doses compared to systemically delivered medications and tailor drug delivery to patient needs. Medtronic recently launched the Control WorkflowSM, an evidence-based approach for use with the Medtronic pain pump that helps physicians wean patients off oral opioids and assists them in identifying patients likely to have positive outcomes with the Medtronic pain pump. It was developed by clinicians and provides comprehensive guidance on therapy initiation, catheter placement, and dosing that could impact successful outcomes with the goal of sustained pain relief and functional improvement.