John A. Hatheway, MD, of Spokane, Wash., enrolled the first patient in the clinical study to evaluate Medtronic's SynchroMed II Intrathecal drug delivery system for patients with primary back pain.
Here are five things to know:
1. The clinical study is examining the use of SynchroMed II as an alternative to oral opioids for chronic, intractable non-malignant primary back pain, both with and without leg pain.
2. The study, titled Embrace TDD, will follow patients who are weaned from oral opioids to receive targeted drug delivery instead. Previous studies show tapering and eliminating oral opioids can improve pain relief and allow for lower intrathecal medication doses when compared with the combination of oral opioids and intrathecal treatment.
3. The prospective, multi-center, post-market study aims to enroll around 100 chronic pain patients at up to 15 sites across the U.S. and follow the patients for one year.
4. The device is designed for implantation under the skin and delivers medication into the intrathecal space. Clinicians can prescribe reduced doses compared to systemically delivered drugs and tailor the dosage to individual needs.
5. To help physicians wean patients off of oral opioids, Medtronic launched ControlWorkflow, an evidence-based approach.