Products for Sacral Neuromodulation
The evaluation allows patients to try the therapy and assess not only its efficacy but also its tolerability and sensation so that they and their physician can make an educated decision whether or not to proceed with an InterStim® System implant. In general, the evaluation is considered a success if the patient experiences a significant reduction in his or her bladder control or bowel control symptoms.
There are two types of evaluation for Sacral Neuromodulation, delivered by the InterStim System: the basic evaluation and the advanced evaluation. Either one can be used to test Sacral Neuromodulation for Bladder Control or Bowel Control. In both evaluations, a portable, external stimulator generates the stimulation which is delivered via a lead; the patient wears this stimulator throughout the evaluation. Patients complete a symptom diary prior to the evaluation to establish a baseline measure of incontinence; and during the evaluation to measure improvement.
The basic evaluation (also referred to as Peripheral Nerve Evaluation or PNE) is initiated through a simple, in-office procedure. The advanced evaluation (also referred to as Stage 1) is initiated through an outpatient procedure performed in a hospital or surgical center. Both evaluations are short-term, and the effects are reversible by removing the leads or turning off the device.
Choose the evaluation option that's best for the individual patient. Here's how the evaluation options compare:
|Basic Evaluation||Advanced Evaluation|
• Available as an initial evaluation option
• Available as an initial evaluation option
|Evaluation period||• Up to 7 days||• Up to 14 days|
|Procedure||• Performed in office||• Performed in hospital outpatient or surgical center|
|Anesthetic||• Local anesthesia||• Monitored anesthesia care or general anesthesia|
|Type of lead||
• Flexible, thin wire
• Flexible lead with tines that anchor into place
|Fluoroscopy||• May or may not be used||• Always used|
When choosing an evaluation option, the clinical assessment of the patient may include:
- Frequency of incontinence episodes (e.g., typical number of episodes per week)
- Patient's comfort level with surgery and the therapy
- Patient size and activity level (tines on the chronic implant lead minimize lead migration in patients who are overweight or active)
Local carrier or payer policies may also influence the choice of evaluation.
Complications can occur with the evaluation including implant site pain, movement of the wire, technical problems with the device, and some temporary pain.
The InterStim System is implanted only if the physician and the patient have identified a successful reduction in the patient's bladder control or bowel control symptoms as a result of the evaluation.
Implanting the system requires a short surgery, typically done as an outpatient procedure. The sacral nerve neurostimulator is inserted under the skin through a small incision in the upper buttock. The long-term lead is implanted under the skin, with one end of the lead connecting to the neurostimulator. The other end of the lead is placed in the sacral foramen adjacent to a sacral nerve. The electrical stimulation, generated by the neurostimulator and delivered by the lead, modulates nerve activity.
In addition to risks related to a surgical procedure such as infection and swelling, neurostimulator or lead related problems may occur and require surgery or cause return of symptoms. For a list of adverse events that have been associated with the therapy, please refer to Indications, Safety, and Warnings. This therapy is not for everyone. A prescription is required.
For detailed information on the InterStim System implant procedure, refer to the InterStim and InterStim II Implant Manual.
The battery life of the neurostimulator will vary depending on the model and stimulation levels. Clinicians should check the neurostimulator battery level at each follow-up visit.
For detailed information on replacing the neurostimulators, refer to the InterStim and InterStim II Implant Manual.
If you need to remove the implanted tined lead, the most effective removal technique is to use gentle traction and pull the lead in a straight, not oblique, line from the lead tines. Pull the lead from the lead introducer site above the sacrum not from the neurostimulator pocket site.
- Open the neurostimulator pocket site using normal surgical procedure and carefully remove the neurostimulator from the subcutaneous pocket.
- Clean the neurostimulator connector block and lead (for Model 3058) or extension connector (for Model 3023) with sterile water; wipe dry with surgical sponges.
- For the InterStim model 3058 neurostimulator, insert a torque wrench through the pre-pierced hole in the rubber sealing grommet of the neurostimulator and loosen the setscrew by turning it counterclockwise. Gently retract the lead from the connector block.
For the InterStim model 3023 neurostimulator: Disconnect the lead from the extension.
- Make a small incision at the lead introducer site above the sacral foramen and expose the lead.
- From the lead introducer site, gently grasp the lead and pull so that the proximal end of the lead travels from the neurostimulator pocket site through the subcutaneous tissue. Continue pulling until the proximal end of the lead has been removed from the body.
- To remove the tined portion of the lead, use gentle traction and pull the lead in a straight, not oblique, line.
- Caution: Do not use more than gentle traction to remove the tined lead. Use only gentle traction. More than gentle traction may cause lead breakage, which can result in unretrieved device fragments. If resistance occurs during lead removal, gentle traction should be stopped to reduce the risk of lead breakage. Additional dissection may be needed to release the lead tines and to remove the entire lead.
- Remove the entire lead.
For more information, please refer to the InterStim Tined Leads Implant Manual.
Chapter 1: Peripheral Nerve Evaluation Procedure(4:58, 25 MB)
This animation presents the peripheral nerve evaluation (PNE, also known as the basic evaluation) procedure for Sacral Neuromodulation delivered by the InterStim System. Detailed procedural instructions are provided in the product technical manual and must be reviewed prior to use.
Chapter 2: Stage 1 Evaluation Procedure(7:15, 35 MB)
This animation presents the stage 1 (advanced) evaluation procedure using a tined lead. Detailed procedural instructions are provided in the product technical manual and must be reviewed prior to use.
Chapter 3: Stage 2 Implant Procedure(3:40, 21 MB)
This animation presents an overview of the stage 2 implant procedure for the InterStim System. The procedure is performed following a successful stage 1 (advanced) evaluation with a tined lead. Detailed procedural instructions are provided in the product technical manual and must be reviewed prior to use.
Chapter 4: Full Implant Procedure(7:00, 30 MB)
This animation presents the full implant procedure for the InterStim System. The full implant procedure involves implantation of the tined lead and neurostimulator following a successful PNE (basic evaluation). Detailed procedural instructions are provided in the product technical manual and must be reviewed prior to use.
Chapter 5: Lead Removal After Unsuccessful Evaluation(3:05, 20 MB)
This animation presents the removal of an InterStim tined lead and connected components following an unsuccessful evaluation. Detailed procedural instructions are provided in the product technical manual and must be reviewed prior to use.
Chapter 1: Overview of Anatomy - Pelvic Floor(5:41, 37 MB)
In this video Dr. Kenneth Peters and Dr. Benjamin Girdler discuss the anatomy of the pelvic floor and the leg, which are involved in Sacral Neuromodulation.
Physician Anatomy Video by Chapter
Chapter 2: Overview of Anatomy - Sciatic and Tibial Nerves(2:33, 16 MB)
Describes the the sciatic and tibial nerves.
Chapter 3: Overview of Anatomy - Sacral Nerves and Sacral Foramina(1:53, 12 MB)
Describes the sacrum and the sacral nerves.
Office-based Peripheral Nerve Evaluation(12:30)
In this video Dr. Karen Noblett demonstrates in-office placement of a temporary lead used for the peripheral nerve evaluation (PNE, also known as the basic evaluation) for Sacral Neuromodulation for Bladder Control (delivered by the InterStim System).
Peripheral Nerve Evaluation: Lead Implantation Without Fluoroscopy(9:12, 60 MB)
This video shows gynecologist Dr. Brian Raybon perform an in-office peripheral nerve evaluation (PNE, also known as the basic evaluation) procedure for Sacral Neuromodulation without the use of fluoroscopy. He demonstrates how to locate spinal processes, mark the entry point for the needles, and place a temporary lead close to the S3 sacral nerve so that Sacral Neuromodulation can be tested on a patient with urinary control problems.
Chapter 1: Overview and Indications(1:30, 7 MB)
Overview of the PNE (also known as the basic evaluation) procedure demonstrated by Dr. Brian Raybon and Dr. Thomas Chun to place temporary lead close to the S3 sacral nerve to test Sacral Neuromodulation on patients with urinary control problems.
PNE Implant with Fluoroscopy Procedure Video by Chapter
Chapter 2: Procedure Preparations(2:29, 15 MB)
Describes pre-surgery procedures including proper positioning of patient, preparing a sterile field, and attaching screener cable and box. Reviews contents of test stimulation kit.
Chapter 3: Locating S3 Foramen(6:10, 38.2 MB)
With the help of fluoroscopy and measurements devices, demonstrates the cross hairs technique used to locate S3 foramen and place a test stimulation needle. Describes now to numb the area, insert needles, and verify stimulation with proper motor and sensory responses from patient.
Chapter 4: Lead Placement(4:17, 27 MB)
Illustrates insertion of temporary leads, rechecking of sensory responses, removing foramen needles and lead stylets, and securing test leads.
Chapter 5: Patient Instructions(1:00, 5 MB)
Outlines instructions to share with patient about using programmer, keeping a voiding diary, and proper activities during the evaluation.
Manuals and Technical Resources
This document includes information about contraindications, adverse events, component disposal, and other information regarding Medtronic Sacral Neuromodulation, delivered by the InterStim System.
This document provides information about indications, warnings, and precautions regarding sacral Sacral Neuromodulation for Bladder Control and Bowel Control, delivered by the InterStim System.
This document summarizes the clinical outcomes of Medtronic Sacral Neuromodulation (delivered by the InterStim System) and includes information about the Medtronic-sponsored clinical trials.
This document includes system and compatibility information about the InterStim and InterStim II systems.
This manual includes instructions for use of the InterStim test stimulation lead kit model 3065U and InterStim test stimulation lead model 3057. The instructions cover suggested procedures including preparation, stimulation, and lead removal.
This document includes a detailed system description, instructions for use, patient instructions, troubleshooting guidelines, and other information about the InterStim test stimulator model 3625.
These are the instructions for using the InterStim II model 3058 and InterStim model 3023 neurostimulator systems.
This manual includes implant procedures and instructions for using the InterStim tined leads models 3093 and 3889.
This manual includes the instructions for use for the quadripolar extension model 3095.
This guide presents technical programming information and usage for the N'Vision® clinician programmer model 8840, which is used with InterStim II and InterStim sacral nerve neurostimulators. The manual includes an overview and description, as well as the use, maintenance, troubleshooting, and specifications of the programmer.
This programming guide provides instructions on how to use the N'Vision Clinician Programmer model 8840 with the corresponding InterStim application card model 8870 to program, adjust, and troubleshoot the InterStim model 3023 and InterStim model 3058 neurostimulator system.
This is the patient user manual for the InterStim iCon® model 3037 patient programmer.
This guide includes high-level programming features for the InterStim iCon patient programmer model 3037.
This guide is designed to help patients understand how the InterStim System works and to answer questions they may have about how the therapy may affect their day-to-day life.