Medtronic has received FDA approval for a device that allows pain patients to make their implants deliver doses on demand.
The add-on to the SynchroMed II intrathecal drug delivery system enables patients to adjust their dosing in response to unexpected pain, potentially reducing their need for systemic oral opioids.
Medtronic developed the smartphone controlled self-administration device in collaboration with Samsung after studies linked the combination of implants and systemic opioids to patient deaths.
Medtronic's SynchroMed is designed to enable patients suffering from chronic pain to stop taking systemic opioids. The implant releases drugs into the intrathecal space around the spinal cord. A study published in 2015 found 68% of patients with long-term pain stopped taking systemic opioids in the month after receiving the implant. The rate increased to 84% and 92% after one and five years, respectively.
However, while the device cuts the use of systemic opioids, it also creates problems. Some of the past problems, which led Medtronic to sign a consent decree with the FDA in 2015, relate to the risk of under and over-infusion by the device itself. Other problems stem from concomitant medications.
As pain can overwhelm the dose administered by Medtronic's device, some patients continue to take short-acting opioids periodically after receiving the implant. In the 2015 study, 9% of subjects took short-acting opioids six months after implantation. Typically, these patients took small doses to stop breakthrough pain. In the real world, the use of short-acting opioids by patients with implants has been linked to deaths.
To provide such patients with a safer way to manage breakthrough pain, Medtronic developed myPTM. The product is an application that runs on a touchscreen Samsung device. Physicians program therapeutic limits. After that, the patient can use it to deliver extra doses on demand.
"Pain is very personal and can be unpredictable," John Hatheway, owner of Northwest Pain Care, said in a statement. "Enabling patients to adjust their treatment provides them with some independence to control their pain and gives me confidence knowing that they are getting pain relief without oral opioids."
The device is a product of Medtronic's collaboration with Samsung. After striking back-to-back deals in diabetes and pain in 2015, the partners have worked to enhance Medtronic’s devices through the use of technology. The myPTM approval comes a year after the FDA cleared a Samsung tablet-based system for managing Medtronic’s spinal cord stimulator.