FDA Approves Medtronic Pain Pump App

Are your patients taking too many oral opioids? Medtronic plc says it has an app for that.

On October 12, 2018, the FDA approved the company’s new SynchroMed II myPTM Personal Therapy Manager for patients with chronic pain. The company said the device "enables patients to alleviate their unpredictable pain by delivering on-demand boluses, or drug doses, within therapeutic limits set by their physician."

According to FDA documents, this is the 317th Supplemental Approval to the original SynchroMed Infusion System approved by the agency back in 1988. The agency took about a month to approve this submission.

The original approval stated the device, known as the “Medtronic Pain Pump”, is indicated for "chronic intravascular infusion of floxuridine (FUDR) or doxorubicin hydrochloride (Adriamycin) and, when required bacteriostatic water, physiological saline and/or heparin."

myPTM

According to the company, myPTM is an application on a touchscreen Samsung J3 smart device that is customized to let patients manage their pain. "Healthcare providers can set daily therapeutic doses and allow for on-demand bolusing, or drug delivery, within pre-established limits. myPTM features clear bolus delivery, access to therapy details, and lockout alerts if patient demand exceeds prescribed limits. Physicians also have access to reports that provide insights needed to track progress and collaborate on therapy goals with their patients."

The app works with the pain pump to deliver medication directly to the fluid around the spinal cord to relieve chronic pain in appropriate patients. "The Medtronic pain pump provides effective pain relief at a fraction of the oral dose and with fewer side effects and has been shown to reduce or eliminate the use of oral opioids.”

"Given the current opioid epidemic and ongoing pain management crisis, it’s more important than ever for the millions of patients suffering from chronic pain to have access to long-term alternatives to systemic opioids."

The company says targeted drug delivery (TDD), "may enable systemic opioid reduction or elimination and may be considered as an alternative to oral treatment for chronic pain. In a single-center, retrospective chart review (n=99) of patients with chronic non-malignant pain who agreed to transition from systemic opioids to TDD with the goal of eliminating systemic opioids, 84% were able to eliminate systemic opioids within one year."

John A. Hatheway, M.D., owner and provider at Northwest Pain Care in Spokane, Washington, said, “Pain is very personal and can be unpredictable. myPTM is a simple, easy-to-use device that allows my patients to personalize their treatment based on their day-to-day needs. 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 Medtronic pain pump and myPTM are powerful tools to safely treat chronic pain including intractable cancer pain.”

Last August the company issued a Class 2 Device Recall of the system's pump. The company then implemented a final design change intended to address a motor stall due to corrosion and recalled devices with the previous design that were not implanted.