Products and Procedures

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.

In a clinical study:

• 97% of patients with spasticity of spinal origin demonstrated a positive response to the screening test¹
• 86% of patients with spasticity of cerebral origin demonstrated a positive response to the screening test²

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

Single Injection

The patient is injected with a single bolus injection of intrathecal baclofen, via a lumbar puncture. The dose is typically 50 mg per day. 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 drug package insert for procedure and dosing recommendations (for adults and pediatric patients) and a complete list of warnings, precautions, and contraindications.

For detailed information on preparing for and implementing a screening test, refer to the SynchroMed II Clinical Reference Guide - Severe Spasticity Management chapter..

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:

Preoperative Tasks

• Conduct patient and caregiver education
• Determine initial dose
• Assemble equipment and supplies
• Check initial pump status
• Prepare drugs and solutions
• Identify pump site

Intraoperative Tasks

• Prepare the patient
• Prepare the pump for implant
• Implant the intrathecal catheter and pump
• Record patient information

Postoperative Tasks

• 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

For detailed information on the ITB Therapy implant procedures, including information on the prevention and management of surgical complications, refer to the SynchroMed II Clinical Reference Guide – Surgical Procedures chapter.

Also refer to Important Safety Information.

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.