Medtronic has enrolled first patient in its Embrace targeted drug delivery (TDD) clinical trial designed to assess the efficacy of SynchroMed II intrathecal drug delivery system.
Also known intrathecal drug delivery system, SynchroMed II is being tested as an alternative to oral opioids for patients with chronic intractable non-malignant primary back pain with or without leg pain.
SynchroMed II pain pump will offer better pain relief at a fraction of the oral dose with less side effects and help avoid tthe use of oral opioids.
Embrace TDD trial is a prospective, multi-center and post-market study, which will recruit around 100 patients with chronic intractable non-malignant primary back pain with or without leg pain at up to 15 sites in the US.
The study has been designed to better understand the impact of an opioid-free period prior to TDD treatment on patient outcomes.
Embrace TDD study is said to follow patients who wean completely from all oral opioids and have a successful intrathecal drug trial.
Medtronic pain therapies’ targeted drug delivery general manager and vice president 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.”
Medtronic pain pump and catheter are placed under the skin and deliver medication into the intrathecal space, helping clinicians to prescribe reduced doses compared against systemically delivered medications and make drug delivery as per patient requirements.
The company has recently introduced Control WorkflowSM evidence-based approach to be used with pain pump to enable physicians wean patients off oral opioids and help them in identifying patients expected to have positive outcomes with the pain pump.
The evidence-based approach offers comprehensive guidance on therapy initiation, catheter placement and dosing, helping to deliver positive outcomes for sustained pain relief and functional improvement.