SynchroMed^® Programmable Infusion System

Medtronic SynchroMed® II Programmable Drug Infusion System

The Medtronic SynchroMed^® Programmable Infusion System is a family of implantable and external products. The SynchroMed programmable pumps and intrathecal catheters are completely implantable. The clinician programmer is an external component that uses telemetry to communicate with the pump. Other SynchroMed system components include the refill kits used to empty and refill the pump and the catheter access port kit used in diagnostic procedures.

Indications

The SynchroMed II programmable drug infusion system is indicated for:

• Chronic intrathecal infusion of Lioresal^® Intrathecal (baclofen injection) in the management of severe spasticity
• Chronic epidural/intrathecal infusion of preservative free morphine sulfate sterile solution (and preservative-free morphine hydrochloride outside of the United States) in the treatment of chronic intractable pain
• Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain
• Chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer
• The SynchroMed EL system is also indicated for:

• intravenous infusion of clindamycin for the treatment of osteomyelitis
• Chronic intravascular infusion of doxorubicin or cisplatin for the treatment of primary or metastatic cancer

For more information on the indications, contraindications, warnings, and precautions for the SynchroMed programmable infusion systems, please review the device brief summaries for the SynchroMed II Drug Infusion System and the SynchroMed EL Infusion System.

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