FDA approves new clinician programmer for SynchroMed II intrathecal drug delivery system


The US Food and Drug Administration (FDA) has approved a new clinician programmer for use with the SynchroMed II Intrathecal Drug Delivery system (Medtronic), an implantable pump that provides targeted drug delivery for chronic pain and severe spasticity.

The SynchroMed II pump delivers medication directly to the fluid around the spinal cord, which provides relief at lower doses compared to oral medications in appropriate patients with chronic pain or severe spasticity. The new SynchroMed II clinician programmer was designed to simplify therapy management by providing clinicians with visual tools and intuitive workflows.

“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,” says Joshua Wellington, Indiana University Health, USA. “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.”

The SynchroMed II clinician programmer is an application that runs on a tablet that includes a vibrant screen display and simple, guided workflows. The programmer features visual enhancements such as side-by-side comparison of therapy changes and flex dosing graphics. The clinician programmer communicates wirelessly to the SynchroMed II pump and auto-calculations help ensure accuracy and improve programming confidence. Medtronic also recently secured FDA approval and implemented four design changes to improve the design and performance of the SynchroMed II Pump.

“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,” says Charlie Covert, vice president and general manager, Targeted Drug Delivery, Medtronic Pain Therapies. “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.”


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