Medtronic receives FDA approval for SynchroMed III system
Medtronic has received U.S. Food and Drug Administration (FDA) approval of its next-generation SynchroMed III intrathecal drug delivery system for patients with chronic pain, cancer pain, and severe spasticity.
SynchroMed III is a targeted drug delivery (TDD) platform that alleviates symptoms by delivering medication directly to the fluid surrounding the spinal cord. SynchroMed III is an upgraded system compared to the SynchroMed II system, featuring a new “refill only” physician workflow for more efficient programming, improved electronics with firmware capable of being updated after implant, and additional protections for patient data through enhanced cybersecurity. The system also carries forward several mid-generation durable design enhancements from the SynchroMed II pump which have contributed to the long-term safety and reliability of the device.
TDD therapy is a safe, proven, and effective way to manage chronic pain, cancer pain or severe spasticity with greater efficacy, fewer side effects, and a high degree of clinician control as compared to systemic medication. The system delivers medication directly to the fluid surrounding the spinal cord via a catheter connected to a small, battery-powered programmable pump. Patients with the SynchroMed III system will continue to have access to diagnostic imaging through industry-leading 1.5T and 3T full-body MRI conditionality.
Dr. Chris Beuer, the director of pain management at Christian Hospital in St. Louis, Missouri, said: “Targeted drug delivery is a critically important therapy for the management of chronic pain, cancer pain or severe spasticity when oral medications are ineffective or cause intolerable side effects. Systemic opioids bring significant risks, so I am pleased to be able to offer targeted drug delivery to my patients as a safe and effective alternative. I’m also excited about the new refill-only workflow capabilities of the SynchroMed III system which will enable more efficient programming within my practice.”
The SynchroMed III system can be used with the Control Workflow, which is designed to help eliminate the use of systemic opioids by certain patients. Control Workflow is a framework that can be tailored to individual patients and assists physicians in identifying patients likely to have positive outcomes. It supports oral opioid tapering and drug holidays, allowing for treatment with the lowest effective dose of intrathecal medication, which may improve pain relief compared to a combination of oral and intrathecal treatment. This evidence-based approach was developed by clinicians and provides comprehensive guidance on therapy initiation, catheter placement, and dosing that could impact successful outcomes with the goal of sustained pain relief and functional improvement.
David Carr, vice president and general manager, Pain Interventions within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic, said: “Medtronic has offered targeted drug delivery therapy for over 30 years, and we continue to further enhance this technology. The SynchroMed III system brings forward several important developments and represents another step forward in our commitment to delivering solutions that alleviate pain and improve lives through innovative medical technology.”
The SynchroMed III system will be commercially available later this calendar year.