Medtronic has received the US Food and Drug Administration (FDA) approval for its SynchroMed III intrathecal drug delivery system for chronic pain, cancer pain, and severe spasticity.
SynchroMed III is a targeted drug delivery (TDD) platform, intended to reduce the symptoms by delivering medication directly to the fluid surrounding the spinal cord.
TDD therapy is a safe and effective way to manage chronic pain, cancer pain or severe spasticity, with fewer side effects and more clinician control than systemic medication.
The system features a new ‘refill only’ physician workflow for effective programming, improved electronics that allow updating after implant, and enhanced cybersecurity for patient data protection.
Also, the new-generation system continues several mid-generation durable design enhancements from the SynchroMed II pump, for long-term safety and reliability.
Medtronic intends to start commercialising its SynchroMed III system later this year.
Medtronic pain interventions vice president and general manager David Carr 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 works by delivering medication directly to the fluid surrounding the spinal cord through a catheter connected to a small, battery-powered programmable pump.
Patients implanted with the SynchroMed III system can undergo diagnostic imaging through 1.5T and 3T full-body MRI conditionality.
The new-gen drug delivery system can be used with the Control Workflow, which helps prevent the use of systemic opioids by certain patients.
Control Workflow can be customised to individual patients and helps physicians identify patients likely to have positive outcomes, said the medical technology company.
Christian Hospital in St. Louis pain management director Chris Beuer 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.”
