The FDA has approved a new clinician application for Medtronic‘s (NYSE:MDT) SynchroMed II intrathecal drug pump. The newly-approved programmer was designed to give doctors visual tools and improved workflows to simplify therapy management.
The medtech titan’s implantable pump, which has been problematic in the past, delivers drugs directly to the fluid around the spinal cord.
The SynchroMed II’s clinician app runs on a tablet that features a vibrant display and simplified workflows, according to Medtronic. The programmer includes side-by-side comparison of therapy changes and flex dosing graphics, as well the ability to communicate wirelessly with the pump.
“With the ongoing opioid crisis, the ability to reduce the use of systemic opioids and effectively manage my patients’ pain with the SynchroMed II pump system is more important than ever,” Indiana University Health’s Dr. Joshua Wellington said in prepared remarks. “The new SynchroMed II clinician programmer helps simplify therapy management, enabling me to focus on providing my patients with pain relief through intrathecal delivery of medications so that systemic opioids are reduced or eliminated entirely.”
Late last year, Medtronic won FDA approval to implement design changes to the SynchroMed II pump. The move comes after years of problems with the pump, like a 2013 recall that the FDA issued over a risk of over-infusion.
“Our new clinician programmer follows a series of recent SynchroMed II Pump design changes and was developed with patient safety in mind; our goal was to make it intuitive and simple for clinicians to confidently tailor treatments to best meet patients’ needs,” Charlie Covert, Medtronic’s VP & GM of targeted drug delivery for the company’s pain therapies business, added. “The ability to assist with decreasing the need for systemic opioids is critical, and Medtronic is committed to improving the lives of patients with chronic pain and severe spasticity through continuous innovation and therapy advancements.”