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|FDA Approves Innovative Clinician Programmer for the Medtronic SynchroMed II Intrathecal Drug Delivery System for Chronic Pain and Severe Spasticity|
SynchroMed(TM) II for Chronic Pain Is an Alternative to Systemic Opioids for Many Patients
DUBLIN - January 10, 2018 - Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval of a new clinician programmer for use with the SynchroMed(TM)II Intrathecal Drug Delivery system, 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 pain1 or severe spasticity.2 The new SynchroMedII clinician programmer was designed to simplify therapy management by providing clinicians with visual tools and intuitive workflows and will soon be available in the U.S.
"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," said Joshua Wellington, M.D., Indiana University Health. "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," said 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."
Targeted Drug Delivery, An Alternative to Oral Opioids
About Chronic Pain and Severe Spasticity
About SynchroMedII Intrathecal Drug Delivery System
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.