FDA Approves SynchroMed for Patient-Directed Chronic Pain Management

The US Food and Drug Administration (FDA) has approved a device for patient-managed pain control—the SynchroMed II myPTM Personal Therapy Manager. The device allows patients with chronic pain, including those with heart disease, cancer, and diabetes, to manage unpredictable pain by delivering on-demand doses within limits set by their provider.

"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," said John A. Hatheway, MD, owner and provider at Northwest Pain Care in Spokane, Washington, 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 Medtronic pain pump and myPTM are powerful tools to safely treat chronic pain including intractable cancer pain."

myPTM is an application accessed through a touchscreen Samsung J3 device that works with the SynchroMed system. Providers can set daily therapeutic doses and establish limits for on-demand doses. Additionally, they can create lockout alerts if patient demand for medication exceeds the established limits.

"Samsung and Medtronic have partnered to offer an innovative solution for patients with chronic pain," said David Rhew, MD, chief medical officer, vice president and general manager for Enterprise (B2B) Healthcare, Samsung Electronics America. "The ability to directly manage one's medical condition from a smartphone device is ground breaking and changes the way we think about the personalization of care."

The SynchroMed II Intrathecal Drug Delivery system—also known as the Medtronic pain pump—delivers pain relieve medication directly to the fluid surrounding the spinal cord through a pump and catheter implanted under the skin. The direct access allows providers to reduce the dosage prescribed compared to systemically delivered pain medications and to tailor a regimen for each patient’s needs.

This system provides long-term pain relief with lower doses and fewer side effects compared to oral pain medication options.

"As the opioid crisis continues, we are inspired by the Medtronic Mission to continue to innovate and expand access to care for patients who may benefit from our therapies, which have the potential to eliminate the need for oral opioids," said Charlie Covert, vice president and general manager of the Targeted Drug Delivery business, part of the Restorative Therapies Group at Medtronic.