Products for Targeted Drug Delivery
Models 8780 and 8781
Intrathecal Drug Delivery Procedure Overview
Medtronic provides clinicians with a straightforward and effective screening test for determining if a patient is a candidate for the SynchroMed® II programmable infusion system for intrathecal drug delivery.
During the screening test, intraspinal morphine is administered via a lumbar puncture or percutaneous catheter and continuous intrathecal/epidural delivery. Patients who have a positive response to the therapy during the screening test may be considered for implantation with the SynchroMed II infusion system. Refer to the drug package insert for procedure and dosing recommendations and a complete listing of Indications, Safety and Warnings.
In general, there are three approaches to the screening test:
- The patient is injected with a single bolus injection of intrathecal morphine, via a lumbar puncture.
Multiple Bolus Injections
- The patient is given a series of injections, either intrathecally or epidurally.
- For epidural administration, administer injections via an epidural catheter inserted under fluoroscopy to ensure proper placement
- Patients may receive a placebo to compare symptom relief
- A catheter is placed either intrathecally or epidurally and connected to an external infusion pump.
- Morphine therapy is tested over a period of days.
The Intrathecal Morphine for Intractable Chronic Pain Management chapter of the SynchroMed Programmable Infusion Systems Clinical Reference Guide provides information about conducting the screening test.
Dr. Caraway: Trialing Procedure(1:05, 13.4 MB)
Dr. David Caraway describes his trialing procedure, which includes an overnight hospital stay and placing a catheter in the fluoroscopy suite to meet Medicare guidelines of an in-dwelling catheter trial.
The SynchroMed II programmable infusion system, which includes the pump and an intrathecal catheter, is implanted in a sterile surgical procedure performed under general or regional anesthesia.
The pump is implanted in the lower abdomen just beneath the skin. One end of the catheter is inserted into the intrathecal space of the spine. The other end of the catheter is then tunneled under the skin and connected to the pump.
Before implantation, a screening test of the intrathecal or epidural drug is necessary. This procedure will help assess if the patient responds appropriately to the medication. Refer to the drug package insert for procedure and dosing recommendations and a complete listing of warnings, precautions, and contraindications.
For a complete description of the intended use, indications, contraindications, warnings, and precautions, refer to the current implant manuals that accompany the products.
For detailed information on intrathecal drug delivery implant procedures, including information on the prevention and management of surgical complications, refer to the Surgical Procedures chapter of the SynchroMed Programmable Infusion Systems Clinical Reference Guide.
Contraindications for Pump Implant
Implantation of the programmable pump is contraindicated:
- When infection is present
- When the pump cannot be implanted 2.5 cm or less from the surface of the skin
- When body size is not sufficient to accept pump bulk and weight
- When contraindications exist relating to the drug; drugs with preservatives; drugs with ph≤ 3
Do not use the myPTM® personal therapy manager accessory to administer opioid to opioid-naïve patients or to administer ziconotide. Blood sampling through the catheter access port is contraindicated.
Contraindications relating to the use of the prescribed drug must be observed. For more information, see Indications, Safety, and Warnings.
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 by incorporating a layer of PET braid into the catheter design.
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 body. 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 Surgical Procedures chapter of the Clinical Reference Guide provides information regarding pump implant, replacement, and removal.
This guide provides an overview of an Ascenda intrathecal catheter implant procedure for intrathecal drug delivery.
Dr. Kim: Optimizing Results(1:33, 19 MB)
Dr. Philip Kim describes the information gathered and steps taken before the implant procedure that can help to optimize results.
The intrathecal drug delivery pump is refilled by inserting a needle through the skin into the pump septum. The refill procedure involves a specific set of steps that must be followed precisely to help ensure patient safety during intrathecal drug delivery. Before clinicians perform refills, they must be trained in the correct procedures.
For more information on the refill procedure for the SynchroMed II pump, refer to the Therapy Maintenance chapter of the SynchroMed Programmable Infusion Systems Clinical Reference Guide.
To hear the different approaches to the refill procedure and processes, view the Approaches to Targeted Drug Delivery videos on that topic.
The Therapy Maintenance chapter of theClinical Reference Guide provides information about the pump refill procedure, the catheter access port procedure, and other information related to therapy maintenance.
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.
For more information on the indications, contraindications, warnings, and precautions for the SynchroMed programmable infusion systems, please review Important Safety Information.
The Surgical Procedures chapter of the Clinical Reference Guide provides information regarding the pump replacement procedure.
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 gives an overview of the eight steps of the refill procedure for the SynchroMed II programmable infusion system and the supplies needed.
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 document contains prescribing information related to the myPTM® device model 8835.
This technical manual provides information about the model 8516 components used for percutaneous access to the epidural or intrathecal space during a pre-implant intraspinal infusion screening trial procedure.
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 manual provides instructions for using the IsoMed constant flow infusion pump model 8472.
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.
This manual provides information for physicians about the myPTM® personal therapy manager model 8835 used with the SynchroMed II programmable infusion system.
This manual provides information for patients about the SynchroMed II infusion system.
This manual provides information for patients about the SynchroMed EL infusion system.
This manual is intended for patients who have the IsoMed infusion pump model 8472.
This is the patient user manual for the myPTM device model 8835.
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 an 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.
This card provides supplemental instructions for refilling Medtronic SynchroMed pumps. Topics include locating and palpating the pump, inserting the needle, emptying the pump, and refilling the pump.
The Critical Actions in the Pump Refill Procedure card supplements the Instructions for Use manuals included with the Medtronic SynchroMed Implantable Infusion Pump refill kits. It should be used in conjunction with these manuals and the Clinical Reference Guide.
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.
This card provides information on the identification of symptoms and suggestions for treatment for morphine intrathecal/epidural overdose.
In view of the increased risk of mortality in the period immediately after implant, revision, and refill of intrathecal pumps and catheters, it is important to emphasize the procedures that can minimize risk during this period.
In 2006, Medtronic, Inc. and a team of noted experts investigated what might have caused the deaths of 3 patients early on in their treatment of pain using intrathecal infusion pumps containing opioids. They augmented their own findings with related data from other large databases.
Mortality rates associated with intrathecal therapy in the 3-day post-implant period and at other selected intervals were measured, and mechanisms of any deaths observed after initiation of intrathecal opioid therapy in patients with non-cancer pain were explored.
- Lamer TJ. Treatment of cancer-related pain: When orally administered medications fail. Mayo Clinical Proc 1994;69:473-80.
- Levy, R. Implanted Drug Delivery Systems for Control of Chronic Pain. Chapter 19 of Neurosurgical Management of Pain. New York, NY: Springer-Verlag; 1997.