Physiatry/Physical Medicine & Rehabilitation

Explore proven technologies to help manage your patients' chronic pain, severe spasticity and movement disorders.

To learn more about Medtronic interventions and devices, and how they can help you better serve your patients, choose an intervention or device.

Interventions for Physiatry/Physical Medicine & Rehabilitation

Deep Brain Stimulation

Deep brain stimulation uses an implanted electrode to deliver electrical stimulation to structures involved in the control of movement within the brain. For more information about Deep Brain Stimulation, please see the Indications, Safety and Warnings.

Intrathecal Baclofen Therapy for Severe Spasticity

ITB TherapySM (Intrathecal Baclofen Therapy) for the management of severe spasticity uses an implantable infusion system to deliver precise amounts of Lioresal® Intrathecal (baclofen injection) directly to the intrathecal space via a surgically implanted pump and catheter. For more information about ITB Therapy, please see the Full Prescribing Information.

Intrathecal Drug Delivery for Chronic Pain

Intrathecal Drug Delivery (IDD) directs prescribed pain medications to the spinal cord—affecting primarily the presynaptic and postsynaptic receptors in the gelatinosa of the posterior horn of the spinal cord. For more information about Intrathecal Drug Delivery, please see the Indications, Safety and Warnings.

Spinal Cord Stimulation

Spinal cord stimulation alleviates pain by electrically activating pain-inhibiting neuronal circuits in the dorsal horn and inducing a tingling sensation (paresthesia) that masks the sensations of pain. For more information about Spinal Cord Stimulation, please see the Indications, Safety and Warnings.

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.

ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. For spasticity of spinal cord origin, ITB Therapy via an implantable infusion system should be reserved for patients unresponsive to oral baclofen or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long-term intrathecal baclofen therapy.

Indications, Safety & Warnings for ITB Therapy: Intrathecal Baclofen Withdrawal: Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at risk (e.g., spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).

This therapy is contraindicated in patients who are hypersensitive to baclofen. Implantation of the infusion system is contraindicated if the patient is of insufficient body size, requires a pump implant deeper than 2.5 cm, or, in the presence of spinal anomalies or active infection.

The most frequent drug adverse events vary by indication but include: hypotonia (34.7%), somnolence (20.9%), headache (10.7%), convulsion (10.0%), dizziness (8.0%), urinary retention (8.0%), nausea (7.3%), and paresthesia (6.7%). Pump system component failures leading to pump stall, or dosing/programming errors may result in clinically significant overdose or underdose. Acute massive overdose may result in coma and may be life threatening.

The most frequent and serious adverse events related to device and implant procedures are catheter dislodgement from the intrathecal space, catheter break/cut, and implant site infection including meningitis. Electromagnetic interference (EMI) and Magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate.

Please refer to the full prescribing information and system information for details or call Medtronic at 1-800-328-0810. Rx Only. Lioresal® is a registered trademark of Novartis Pharmaceuticals Corporation.

January 2008