Healthcare Professionals
SynchroMed II Drug Infusion Pump
Intrathecal Baclofen Therapy with Lioresal® Intrathecal (baclofen injection)
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Healthcare Professionals
SynchroMed II Drug Infusion Pump
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:
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.
SAFETY
CONVENIENCE
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.
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
Changing from simple continuous dosing to flex dosing in ITB Therapy patients may:3
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.†
Access prescriber, implant, MRI, and other manuals on the Medtronic Manual Library Search by the product name (SynchroMed) or model number (8637).
Model | 8637-20 (20 mL reservoir) | 8637-40 (40 mL reservoir) |
---|---|---|
Battery Life | 4 to 7 years | 4 to 7 years |
Weight (empty/full) | 165/185 g (5.8/6.5 oz) | 175/215 g (6.2/7.6 oz) |
Thickness | 19.5 mm (0.78 in) | 26 mm (1.0 in) |
Minimum flow rate | 0.048 mL/day | 0.048 mL/day |
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
Common Adverse Reactions
Serious Adverse Reactions
Postmarketing Experience
For more information, including BOXED WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information, located at lioresal.com/prescribinginformation.
Rev. 06/2019