FDA Approves Clinician Programmer for Medtronic SynchroMed II for Pain, Severe Spasticity


The newly approved system is an alternative to systemic opioids for patients.

fda, Clinician Programmer, Medtronic SynchroMed II, Pain, Severe Spasticity

The US Food and Drug Administration (FDA) announced the approval of a new clinician programmer to use with Medtronic’s SynchroMed II Intrathecal Drug Delivery system for chronic pain and severe spasticity.

The implantable pump provides targeted drug delivery, delivering medication directly to the fluid around the spinal cord and provides relief at lower doses compared to oral medications in those patients with chronic pain or severe spasticity. The delivery system is an alternative to systemic opioids for some patients.

“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 than ever,” Joshua Wellington, MD, Indiana University Health said in a statement. “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 clinician programmer, an application that runs on a tablet, is designed with a vibrant screen display to simplify therapy management by providing clinicians with visual tools and intuitive, guided workflows.

It communicates wirelessly to the SynchroMed II pump, auto-calculating to ensure accuracy.

The Medtronic SynchroMed II pump and catheter are implanted under the skin, delivering medication into the intrathecal space. This allows clinicians to prescribe reduced doses as opposed to systemically delivered medications and tailors drug delivery to specific patient needs.

Those with chronic pain or severe spasticity who haven’t had success with other treatment options, or endure intolerable side effects because of oral medications are viable candidates for the system.

The company recently obtained FDA approval, implementing 4 design changes to improve the design and performance of the pump.

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