Intrathecal Baclofen Therapy with Lioresal® Intrathecal (baclofen injection)
The Medtronic SynchroMed™ II pump is part of the SynchroMed™ II programmable drug infusion system which provides precise drug delivery for chronic therapy for severe spasticity. In addition to the implanted pump, the SynchroMed™ II infusion system uses a catheter to deliver programmed amounts of Lioresal® Intrathecal (baclofen injection) (a muscle relaxant and antispasticity agent) directly to the intrathecal space and cerebrospinal fluid. The pump and catheter are implanted under the skin.
We pursue future innovations to help simplify therapy delivery, including:
The latest Clinician Programmer features simpler, visual, and intuitive workflows to help simplify the programming experience.
We improved the design and performance of the Synchromed™ II pump by completing the implementation of four design changes in 2017.1 We have an unwavering commitment to precision and accuracy.
Chronic infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity of spinal or cerebral origin
Chronic intrathecal or infusion of sterile, preservative-free morphine sulfate for chronic, intractable pain of malignant and/or non-malignant origin
Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain
design changes now implemented to improve performance1
In Pumps Returned and Analyzed for Motor Stall:1
What We've Done:1
Shaft wear is observed in 59%
Applied Diamond-like Carbon Coating to Shaft Projected to address over 99% of shaft wear
Corrosion of the drive gear is observed in 2%
Modified the GearWheel Material Projected to address over 93% of corrosion of the drive gear (Implemented in 2016)
Internal shorting is observed in 14%
Encapsulated the Feedthroughs Projected to address over 96% of internal shorting (Implemented in 2016)
The implementation of these three design changes DOES NOT IMPLY an equivalent percent reduction in motor stall.
SYNCHROMED II CLINICIAN PROGRAMMER
Tablet with touchscreen interface compatible with the SynchroMed™ II pump
Helpful workflow guides and simple steps for refill and implant
Built-in auto-calculations for volume and rates
Visuals accompany prime bolus and flex dosing to help simplify the process
Communicator and the programmer are designed to wirelessly connect enabling flexible and comfortable delivery of patient care within 3 meters
Benefits of the SynchroMed II Pump
Flex dosing schedules allow drug delivery to be matched to patient needs, providing severe spasticity relief throughout the day
Precise dose titration enables clinicians to prescribe the lowest dose to reach patient goals
Smart software guides the clinician through programming the system, via information and warning screens
Full-body MRI compatibility at 1.5 and 3-Tesla under specific conditions*
Critical alarms are triggered at end of service, if a motor stall is detected, critical pump memory error, tube set interval, or if an empty reservoir is estimated
Noncritical alarm sounds for the elective replacement indicator, noncritical pump memory error, or a low reservoir is estimated
Critical therapy and patient data stored in the pump allow flexibility for follow-up at other institutions
180-day drug stability for Lioresal® Intrathecal (baclofen injection)
Clinician programmer features a vibrant touchscreen display, visuals, and workflow guides
The communicator is placed over the pump and is designed to wirelessly connect within 3 meters of the clinician programmer
HOW IT WORKS
The drug enters the pump through the reservoir fill port and passes through the reservoir valve and into the SynchroMed™ II pump reservoir. At normal body temperatures, pressurized gas that is stored below the reservoir expands, exerting constant pressure on the reservoir. This pressure advances the drug into the SynchroMed™ II pump tubing.
The peristaltic action of the SynchroMed™ II pump moves the drug from the pump reservoir, through the pump tubing, check valve, catheter port, and implanted catheter, to the infusion site.
HOW THE SYNCHROMED™ II PUMP OPERATES
The catheter access port (CAP) allows injection of the drug directly into the implanted catheter for drug administration and diagnostic purposes. Drug injected into the CAP bypasses the SynchroMed™ II pump mechanism and goes directly through the catheter port into the implanted catheter to the infusion site.
The SynchroMed™ II programmable pump is noninvasively controlled by the handheld clinician programmer, equipped with an intuitive touchscreen and user-friendly software. The pump can deliver medication at either a constant rate or a variable rate, as deemed therapeutically appropriate by the managing physician.
Studies indicate that programmability may help address fluctuations that accompany severe spasticity.2,3
Flex dosing may improve ITB Therapy results in patients who:3,4
Experience more spasticity at night, which interrupts sleep
Changing from simple continuous dosing to flex dosing in ITB Therapy patients may:3
Treat predictable variation in daily muscle tone
Optimize the benefit received from Lioresal Intrathecal (baclofen injection)
Industry-Leading MRI workflow
Implanting the SynchroMed II infusion pump under the appropriate conditions will not restrict patients from receiving a full-body MRI scan. The SynchroMed II infusion system allows safe full-body access to 1.5 and 3.0-Tesla MRI.* The pump is designed to resume programmed therapy after the scan.†
MANUALS AND TECHNICAL GUIDES
Access prescriber, implant, MRI, and other manuals on the Medtronic Manual Library Search by the product name (SynchroMed) or model number (8637).
8637-20 (20 mL reservoir)
8637-40 (40 mL reservoir)
4 to 7 years
4 to 7 years
165/185 g (5.8/6.5 oz)
175/215 g (6.2/7.6 oz)
19.5 mm (0.78 in)
26 mm (1.0 in)
Minimum flow rate
For additional information please refer to SynchroMed™ II Brief Statement and Lioresal® prescribing information.
Under specific conditions for 1.5 T and 3.0 T MRI scans. Requires interrogation to confirm pump status.
Requires interrogation to confirm pump status.
Medtronic data on file
Rainov NG, Buscher E. Making a case for programmable pumps over fixed rate pumps for the management of fluctuations in chronic pain and spasticity: a literature review. Neuromodulation. 2002;5:89-99.
Krach LE, Kriel RL, Nugent AC. Complex dosing schedules for continuous intrathecal baclofen infusion. Pediatr Neurol. 2007;37:354-359.
Boster AL, Adair RL, et al. Best practices for intrathecal baclofen therapy: dosing and long-term management. Neuromodulation. 2016 Aug;19(6):623-31
Important Safety Information
Indications and Usage
Lioresal® Intrathecal (baclofen injection) is a muscle relaxant and antispastic that is indicated for use in the management of severe spasticity of cerebral or spinal origin.
Lioresal® Intrathecal is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of Lioresal® Intrathecal into the intrathecal space.
For patients with spasticity of spinal origin, Lioresal® Intrathecal via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy 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.
Prior to implantation of a device for chronic intrathecal infusion of Lioresal® Intrathecal, patients must show a response to Lioresal® Intrathecal in a screening trial. Please review the dosing and administration section of the Lioresal® Intrathecal prescribing information for further details.
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 apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).
Hypersensitivity to baclofen
Lioresal® Intrathecal is not recommended for intravenous, intramuscular, subcutaneous or epidural administration.
Select Warnings and Precautions
It is mandatory that all patients, caregivers, and treating physicians receive adequate information regarding the risks of the mode of treatment. Instruction 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 apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS). should be given on signs and symptoms of overdose, procedures to be followed in the event of an overdose, and proper home care of the pump and insertion site.
Due to the possibility of life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure, physicians must be adequately trained and educated in chronic intrathecal infusion therapy.
Patients should be infection-free prior to both a screening trial and a pump implantation. The presence of infection may interfere with an assessment of the patient’s response to bolus Lioresal® Intrathecal (baclofen injection), increase the risk of surgical complications and complicate dosing.
Reservoir refilling must be performed by fully trained and qualified personnel following the directions provided by the pump manufacturer. Extreme caution must be used when filling an FDA approved implantable pump, following strict aseptic technique and ensuring refill directly into the reservoir and not the catheter access port.
An attempt should be made to discontinue concomitant oral antispasticity medication to avoid possible overdose or adverse drug interactions, either prior to screening or following implant and initiation of chronic Lioresal® Intrathecal infusion.
Following pump implantation, and for each adjustment of the dosing rate of the pump and/or concentration of Lioresal® Intrathecal, the patient should be monitored closely until it is certain the patient’s response to the infusion is acceptable and reasonably stable.
Early symptoms of baclofen withdrawal may include return of baseline spasticity, pruritus, hypotension and paresthesias.
Priapism may develop or recur if treatment with intrathecal baclofen is interrupted.
Signs of overdose may appear suddenly or insidiously, and a massive overdose may present as coma. Less sudden and/or less severe forms of overdose may present
with signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.
Should overdose appear likely, the patient should be taken immediately to a hospital for assessment and emptying of pump reservoir.
Delivery of more drug volume than the programmed rate (overinfusion) can result in unexpected overdose, or withdrawal caused by early emptying of the pump reservoir. Refer to the manufacturer's pump manual and instructions for refilling the reservoir.
Except in overdose related emergencies, the dose of Lioresal® Intrathecal should ordinarily be reduced slowly if the drug is discontinued for any reason.
Common Adverse Reactions
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%). Dosing and programming errors may result in clinically significant overdose or withdrawal. Acute massive overdose may result in coma and may be life threatening.
Drowsiness has been reported in patients on Lioresal® Intrathecal. Patients should be cautioned regarding the operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system depressant effects of Lioresal® Intrathecal may be additive to those of alcohol and other CNS depressants.
Serious Adverse Reactions
Seizures have been reported during overdose and with withdrawal from Lioresal® Intrathecal (baclofen injection) as well as in patients maintained on therapeutic doses of Lioresal® Intrathecal.
Fatalities have been reported with Lioresal® Intrathecal use.
The following adverse events have been reported during post-approval use of Lioresal® Intrathecal.
Musculoskeletal – The onset of scoliosis or worsening of a pre-existing scoliosis has been reported.
Urogenital – Sexual dysfunction in men and women including decreased libido and orgasm dysfunction have been reported.
Use in Specific Populations
There are no adequate and well controlled studies in pregnant women. Lioresal® Intrathecal should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing mothers should exercise caution, as oral baclofen has been shown to pass into milk at therapeutic doses.
Safety and effectiveness in pediatric patients below the age of 4 have not been established.
Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with Lioresal® Intrathecal and kept under careful surveillance.
Lioresal® Intrathecal should be given with caution in patients with impaired renal function. Dose reduction may be necessary.
Lioresal® Intrathecal should be used with caution in patients with a history of autonomic dysreflexia.