Medtronic (NYSE:MDT) said today that it enrolled the first patient in a study to assess the use of its SynchroMed II intrathecal drug delivery system as an alternative to oral opioids.
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.
Why would a pain pump catheter become partially occluded?
It can kink up in the spinal area or abdomen area of pump. The leads can come undune. I had a nedtronics 20plus years and it seemed on an off it worked mostly off. I would fall they could not see leads during the pump-o-gram type xray. New leads new pump. They they gotta start with meds back to 1st stage. I had cried fircremival but towards the end drs said no.I have abhugh chance if changing mind. I saidbi have been sayibgvremive for over 15yrs. I out up with it cause I know I needed my oral medication, 3 yrs I was on 300 30mg Oxcodone, 60 8 mg of dilluadid, 120 soma, 90 Diazapam. I called BC/BS FEP an asked did I have to have this medtronics pump that it felt as though it was shocking me, I know it was not working my dr said no BC/BS FEP said yes I have the right for any foreign device to removed from inside me. They recommended a list of neurosurgeons a r mm choose out if county. Pump is out back surgery (not good as i thought) worse pain and fallibg but bottom line 2 30mg ocxycodone, 90 somas n 90 diazapam. PRN..