Products for Intrathecal Baclofen Therapy
Models 8780 and 8781
Intrathecal Baclofen Therapy (ITB Therapy) Procedure Overview
A standard screening test is required to determine whether ITB Therapy may be suitable for patients with severe spasticity. In the test, patients receive an intrathecally administered test dose of baclofen injection via a lumbar puncture. A majority of patients who respond favorably go on to receive ITB Therapy long term. Nonresponse to a low dose may require a trial with a higher dose to demonstrate patient benefit.
ITB Therapy Screening Test Algorithm
- In one clinical study, 94% of patients with spasticity of cerebral origin demonstrated a positive response to the screening test.1
- In one clinical study, 97% of patients with spasticity of spinal origin demonstrated a positive response to the screening test.2
Adverse events from the screening test may include hypotonia, somnolence, headache, dizziness, and nausea/vomiting.
The screening test must be conducted in a medically supervised and adequately equipped environment with immediate access to resuscitative equipment.
Prior to the screening test, clinicians should:
- Educate patient and caregiver regarding the screening test procedure
- Consider titration or discontinuation of concomitant oral antispasmodic medications; some physicians only hold the daily dose on the day of screening
- Prepare for the possibility of significant hypotonia during screening as a result of the bolus injection
The patient is injected with a single bolus injection of intrathecal baclofen, via a lumbar puncture. The dose is typically 50 mcg. For very small pediatric patients, a test dose of 25 mcg may be used.
A screening test is contraindicated in the presence of active infection and in patients who demonstrate hypersensitivity to oral baclofen. Safety and effectiveness in pediatric patients below age of 4 have not been established.
Refer to the Lioresal Intrathecal (baclofen injection) Full Prescribing Information for procedure and dosing recommendations (for adults and pediatric patients) and a complete list of warnings, precautions, and contraindications.
If you have patients who may be candidates for ITB Therapy and you are interested in having them undergo a screening test, contact your Medtronic representative or call Medtronic at (800) 328-0810.
The Medtronic SynchroMed® programmable infusion system, which includes the drug infusion pump and an intrathecal catheter, is implanted in a sterile surgical procedure performed under general or regional anesthesia. The implant procedure typically lasts from 1 to 4 hours.
Key tasks for the implant procedure are divided into three primary categories:
- Conduct patient and caregiver education
- Determine initial dose
- Assemble equipment and supplies
- Check initial pump status
- Prepare drugs and solutions
- Identify pump site
- Prepare the patient
- Prepare the pump for implant
- Implant the intrathecal catheter and pump
- Record patient information
- Program the pump
- Complete pump and catheter registration
- Manage and prevent postoperative complications
- Conduct patient and caregiver education
- Schedule the first refill appointment
The intrathecal catheter is inserted at the mid-lumbar region of the spine using a paramedian-oblique method and then advanced, typically under fluoroscopy, to the lower thoracic spine. After catheter position and adequate cerebrospinal fluid flow are verified, the catheter is anchored to spinal ligaments. The pump must be placed in the abdominal region at a depth of no more than 2.5 cm beneath the skin. The catheter is then tunneled to the abdominal pump implant site for connection to the prepared pump.
The pump is filled with drug before connection to the catheter but typically is not programmed for delivery until the pump is secured to the pocket, incisions are closed, and dressings are applied. The potential for complications associated with pump and catheter implantation reinforces the importance of meticulous implant technique.
Some complications may be directly related to suboptimal implantation technique:
- Catheter fracture/break
- Catheter kink/occlusion
- Catheter dislodgement/migration
- Pump pocket or system infection
These complications can be minimized by the use of specific methods for catheter placement, systemic antibiotic prophylaxis, attention to pump pocket location, secure pump to fascia using suture loops, and proper wound closure techniques.3
Also refer to Important Safety Information.
Impact of Ascenda Catheter on Implant Procedure
The overall implant procedure for the Ascenda® Intrathecal Catheter Model 8780 and 8781 remains relatively the same as previous catheter model procedures with only minor changes to simplify the implant process. Guidewire removal, anchor placement, and catheter connection are designed to result in less procedural variability and greater ease of implant.
The guidewire is now secured within the catheter during catheter placement by using an interlock handle. The inner lumen of the catheter is maintained and is less susceptible to collapse (i.e., kinking), allowing for easier guidewire removal.
In addition, the Ascenda catheter allows for easier insertion of the anchor into the fascia through use of a bi-wing anchor and anchor dispenser. The anchor dispenser provides catheter protection during suturing given that the bi-wing anchor is preloaded on the anchor dispenser. The bi-wing anchor also provides 2 suture points.The new catheter-to-catheter assembly process no longer requires inserting strain relief sleeves on the catheter segments as they are now built into the Ascenda catheter connector. Catheter segments are inserted into either end of the catheter connector and the connector ends are pushed toward the center until an audible snap is heard.
The SynchroMed II infusion system has an expected longevity of 4 to 7 years, depending on the flow rate. Some pumps with flow rates above 0.9 mL/day may reach their end of service prior to the 7-year maximum battery life. However, the majority of SynchroMed II pumps are programmed to have a flow rate below 0.9 mL/day and are expected to last up to 7 years.
When a SynchroMed II infusion system reaches end of service at 7 years, it is designed to automatically shut off. This automatic shutoff helps ensure safe therapy transition by avoiding unpredictable failures that could occur as the pump's mechanical components age.
The SynchroMed II pump was launched in the U.S. in June 2004. As expected, the first pumps implanted began reaching the normal end of service in June 2011.
View details about the Elective Replacement Indicator (ERI) and End of Service (EOS).
For detailed information of pump replacement procedures, refer to the SynchroMed II Clinical Reference Guide – Surgical Procedures chapter.
For more information on the indications, contraindications, warnings, and precautions for the SynchroMed programmable infusion systems, please review Important Safety Information.
- Gilmartin R, Bruce D, Storrs BB, et al. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol. 2000;15:71-77.
- Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years experience. J Neurosurg. 1992;77:236-240.
- Follett KA, Burchiel K, Deer T, et al. Prevention of intrathecal drug delivery catheter-related complications. Neuromod. 2003;6(1):32-41.
Chapter 1: Pump Preparation(5:48, 23 MB)
The SynchroMed II infusion pump must be properly prepared before it is implanted. Preparation of the pump takes place in the operating room and takes about 5 minutes. This video shows the pump preparation procedure and the supplies needed.
Implant Procedure by Chapter
Chapter 2: Implant Procedure(15:23, 84 MB)
This video provides an overview of the pump and catheter implant procedure for the SynchroMed II programmable infusion system.
Chapter 3: Using the Anchor Removal Tool(1:45, 11 MB)
In this video, David Schultz, MD, describes situations where an anchor removal tool may be needed. Instructions for using the anchor removal tool are also included in the video.
Chapter 4: Loading the Anchor Dispenser Tool(:23, 1 MB)
The Ascenda® catheter's anchor dispenser tool secures the anchor to the catheter without the need for suturing. This short video shows how to load the spinal segment of the catheter into the anchor dispenser tool.
Chapter 5: Connecting the Catheter Segments(:30, 1 MB)
The Ascenda catheter ensures a secure connection between the spinal and pump catheter segments by using a simple snap-together connector that features built-in strain relief sleeves called collets. This short video shows how to connect the pump and spine segments of the Ascenda catheter using the connector.
Chapter 6: Additional Implant Considerations(3:14, 10 MB)
This video provides post-operative considerations, such as programming the pump in the operating room immediately following the implant procedure, pain management, and the prevention of post-operative complications. The video also describes special considerations for large patients and for pediatric patients.
Chapter 7: Preventing Catheter Complications(3:42, 12 MB)
Clinical studies and surveys indicate that the rate of catheter-related complications associated with intrathecal drug delivery may be reduced by following specific surgical methods. This video demonstrates catheter complications that can occur and recommends methods that may lead to lower complication rates.
Complete SynchroMed II Refill Procedure(24:19, 173 MB)
This video demonstrates the correct procedures for refilling a SynchroMed II pump.
Reservoir Valve Activation(:55, 4 MB)
During a refill, the inability to inject the fluid or unusual resistance before the maximum reservoir volume is injected may mean that the reservoir valve has been activated. This video describes what to do when the reservoir valve has been activated.
Chapter 1: CAP Procedure Overview(3:25, 22 MB)
The SynchroMed II pump has a catheter access port (CAP septum) located on the apex of the pump. This video provides an overview of the catheter access port and the supplies needed for the CAP procedure, plus a brief overview of the procedure.
CAP Procedure by Chapter
Chapter 2: Complete CAP Procedure(4:35, 32 MB)
This video shows the complete catheter access port procedure.
This document includes information about contraindications, adverse events, component disposal, and other information regarding Medtronic SynchroMed® and IsoMed® infusion systems.
This is the package insert for Lioresal® Intrathecal (baclofen injection).
This manual provides instructions for using for the SynchroMed II programmable infusion pump model 8637.
This manual provides instructions for using the SynchroMed EL programmable drug infusion pump model 8626, 8626L, 8627, and 8627L.
This is the instructions-for-use manual for the catheter access port kits for use with Medtronic SynchroMed II pump.
This technical manual includes the instructions for using the Ascenda® intrathecal catheter model 8780.
This technical manual includes the instructions for using the Ascenda intrathecal catheter model 8781.
This implant manual includes instructions for using the intrathecal catheter and sutureless connector model 8731SC.
The manual for revision kit model 8782 is used to make revisions to the spinal segment of the Ascenda intrathecal catheter models 8780 or 8781.
The manual for the Model 8784 Ascenda Pump Segment Revision Kit is used when a revision to the pump segment of the model 8780 or model 8781 Ascenda intrathecal catheter is required.
This manual provides instructions for using the intrathecal catheter distal revision kit model 8598A to replace parts for the spinal section of intrathecal catheters model 8731 and model 8731SC.
This manual provides instructions for using the sutureless pump connector revision kit model 8578 for intrathecal catheter models 8709 and 8709SC.
This manual provides instructions for using the revision kit model 8596SC when a revision to the pump segment of the intrathecal catheter model 8731 or model 8731 is required.
The manual for the Model 8785 Ascenda Accessory Kit is used when spare parts are required for Ascenda intrathecal catheter models 8780, 8781, 8782 and 8784.
This reference manual contains information specifically regarding indications, drug stability, and emergency procedures for the SynchroMed and IsoMed infusion systems.
This document provides instructions for refilling the pump reservoir of Medtronic implantable programmable infusion pumps with refill kit model 8551/856X.
This manual presents technical information for the N'Vision® clinician programmer model 8840, including an overview and description as well as the use, maintenance, troubleshooting, and specifications of the programmer.
This programming guide provides SynchroMed II pump model 8637 programming instructions for the software application card model 8870 software version B, using the N'Vision clinician programmer.
The seven chapters of the SynchroMed Programmable Infusion Systems Clinical Reference Guide offer in-depth information on various aspects of this programmable pump, used for the management of chronic pain and severe spasticity. The chapters include Intrathecal Morphine for Intractable Chronic Pain Management, Intrathecal Baclofen Therapy for Severe Spasticity Management, Surgical Procedures, Therapy Maintenance, Programming, System Components, and myPTM Personal Therapy Manager.
This guide provides an overview of a Ascenda intrathecal catheter implant procedure for intrathecal drug delivery.
This guide provides a detailed overview of programming the SynchroMed II programmable infusion system with the N'Vision clinician programmer.
Emergency procedure information for underdose and overdose of Lioresal Intrathecal (baclofen injection).
Medtronic has confirmed through engineering analyses that the use of indicated and nonindicated drug formulations can result in collection of CSF protein in the catheter lumen, distal end. Although this may occur with any drug, nonindicated drug formulations can result in significantly increased collections of material in the catheter lumen resulting in complete occlusion of the catheter.
ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. 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.
Important Safety Information 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). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information.
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 (800) 328-0810.
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