Medtronic (NYSE:MDT) said today that the FDA approved its new SynchroMedII myPTM personal therapy manager intended for use in treating patients with chronic pain.
The newly cleared device works with the company’s SynchroMedII intrathecal drug delivery system and is designed to handle delivering on-demand boluses within therapeutic limits set by physicians, the Fridley, Minn.-based company said.
The implantable SynchroMedII pump delivers medication directly to the fluid around the spinal cord to relieve chronic pain with lower doses compared to oral pain medication.
Medtronic said that the myPTM system, which runs as an application on a touchscreen Samsung J3 device, allows healthcare providers to set daily therapeutic doses that allow for on-demand bolusing within pre-established limits. The system is required to clear bolus delivery, and can be set with lockouts and alerts if demands exceed preset limits.
“Samsung and Medtronic have partnered to offer an innovative solution for patients with chronic pain. 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,” Samsung Electronics America’s Enterprise Healthcare GM Dr. David Rhew said in prepared remarks.
“We are striving to simplify targeted drug delivery therapy to make it more accessible. The Control WorkflowSM and clinician programmer provide physicians with tools to effectively administer the therapy, and the myPTM provides customized pain relief options for patients. 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,” Medtronic targeted drug delivery biz GM Charlie Covert said in a press release.
Earlier this month, Medtronic said that it launched its Control Workflow system in the U.S. for use with its SynchroMed II intrathecal drug-delivery system.
