FDA Approves Personal Therapy Manager for Intrathecal Device
A PPM Brief
FDA has approved a new Personal Therapy Manager (myPTM) for chronic pain from Medtronic (Minneapolis, MN), that works with the company's SynchroMed II intrathecal drug delivery system, according to a company press release.1 The SynchroMed II pump and catheter is implanted under the skin and delivers pain medication into the intrathecal space.
The SynchroMed II Intrathecal Drug Delivery system, also known as the Medtronic pain pump, provides pain relief at lower doses and with fewer side effects compared to oral pain medications and may allow some patients to eliminate the use of systemic opioids, according to the company. Patients with chronic, intractable pain who have been unsuccessful with other treatment options or have experienced intolerable side effects with oral medications are candidates for the SynchroMed II myPTM system.
"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 Hatheway, MD, of Northwest Pain Care in Spokane, WA, in the company’s press release.
The additional benefit of personalization provides patients the ability to alleviate unpredictable pain on their own. Through the system, a physician can set daily therapeutic dose limits, which alerts him/her if patient demand exceeds these limits. Physicians can also access usage reports to help track progress and collaborate on important therapy goals. The myPTM application is available on Samsung J3 smart devices that are customized to help patients manage their pain.