FDA approved a new clinician programmer for use with Medtronic's SynchroMed II intrathecal drug delivery system, an implantable pump that provides targeted drug delivery for patients suffering from chronic pain and severe spasticity. The new technology was designed to simplify therapy management for clinicians by providing them with visual tools and intuitive workflows.
The SynchroMed II clinician programmer is a new application that can be used on a tablet and features visual enhancements for a side-by-side comparison of therapy changes. The new app also communicates wirelessly to the SynchroMed II pump with automated calculations to ensure accuracy and improve programming confidence.
Charlie Covert, vice president and general manager of targeted drug delivery for Medtronic pain therapies, said the new drug delivery system was specifically designed to be an intuitive and easy-to-use platform to help clinicians safely and effectively treat patients, without the need for dangerous opioids.
“Our new clinician programmer follows a series of recent SynchroMed II pump design changes, and was developed with patient safety in mind,” he said. “Our goal was to make it intuitive and simple for clinicians to confidently tailor treatments to best meet patients’ needs. 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.”
The systemic abuse of opioid drugs has become an epidemic in the United States, with the CDC citing nearly half of all opioid overdose deaths in 2016 involving prescription opioids. Medtronic’s SynchroMed II is just the latest in a string of new emerging technologies designed to curb opioid dependency.
With more than 100 million American adults suffering from chronic pain — a number that beats out those affected by heart disease, cancer, and diabetes combined — more and more patients are turning to opioid treatments Medtronic’s new targeted drug delivery system aims to help reduce the systemic use of opioid prescription drugs, and could also serve as an alternative to oral treatment for chronic pain.
For now, patients with chronic, intractable pain or severe spasticity who have not had any success with other treatment options are candidates for SynchroMed II. The system is also full-body MRI conditional, as the pump and catheter are implanted under the skin to deliver medication into the intrathecal space. Medtronic hopes that with the new technology, clinicians will be able to prescribe reduced doses compared to systemically delivered medications, enabling them to tailor drug delivery individually with each patient.
In addition to the clinician programmer, Medtronic also received FDA approval on four new design changes that have been implemented on the SynchroMed II pump. The new design changes aim to improve the design and performance of the pump as the company prepares to launch the drug delivery system in the United States.