Unsure about a few things? Below, you’ll find answers to common questions about Medtronic targeted drug delivery. Don’t see your question here? Ask your doctor, or find a specialist near you who can answer your questions.

General Questions About Targeted Drug Delivery

Many people experience significant improvement in their pain symptoms and quality of life after receiving Medtronic targeted drug delivery. However, realistic expectations are essential to being satisfied with any pain treatment. Targeted drug delivery does not eliminate the source of the pain, so the amount of pain relief varies from person to person. Targeted drug delivery is not a cure for chronic pain, but rather a therapy to help you manage your pain.

Your targeted drug delivery system will not provide relief from other types of pain such as headaches, stomachaches, fractures, etc.

Talk to your doctor to determine the kinds of pain treatments that may work for you. The choice of treatment depends on the type of pain, its severity, and your response to your pain treatment. If your doctor thinks you are a good candidate for the pain pump, you can complete a screening trial to see if targeted drug delivery will provide adequate pain relief.

No. The U.S. Food and Drug Administration approved the Medtronic programmable implantable drug pump as safe and effective for the treatment of chronic pain in 1991.

Many insurance companies will pay for targeted drug delivery. However, as with many pain treatments, your doctor will have to get approval from your insurance company before you can receive treatment. Your out-of-pocket costs will vary according to your insurance plan. Consult your doctor or insurance carrier for more specific information.

Medicare will pay 80% of the cost as long as the procedure is determined to be medically necessary. Talk to your doctor about the Medicare Conditions of Coverage.

Questions About the Screening Trial for Targeted Drug Delivery

This will vary depending on the type of screening trial your doctor believes will be best for you. The trial could take as little as a day, and up to 4 days. Depending on the type of screening trial, you may undergo a procedure that takes approximately 1 to 2 hours plus additional time to be monitored in the hospital or surgery center after the procedure. Talk with your doctor to understand the details of the type of screening trial that your doctor thinks would be best for you.

Complications can occur with the screening trial, including bleeding, infection, and drug side effects. The catheter may need to be replaced. You should not undergo a screening trial if you have an active infection at the time of the trial, have a body size too small to accommodate an implanted pump, or if you are allergic to the screening medication.

It depends on your pain level and your doctor. Your doctor may withdraw oral pain medications 1 or 2 weeks prior to the screening trial. However, you may be given oral medication during the screening trial for breakthrough pain. Never change the way you take your prescribed pain medication without first consulting your doctor.

Your pain relief may differ slightly. During the recovery period, your doctor will slowly adjust the medication dose so you receive the best pain relief possible. This is because the medication dose may be different than the dose used during the screening trial. Be sure to tell your doctor about the way you feel, so changes can be made to optimize your therapy. It may take some time to find the dose that works well to manage your pain—this is called “titrating” the dose.

If the screening trial is successful, you and your doctor will discuss when the system (drug pump and catheter) should be implanted. There is typically a waiting period between the screening trial and the implant procedure. This will give time for your insurance provider to be notified and your surgery to be scheduled.

Questions About Long-term Targeted Drug Delivery

In long-term therapy, the targeted drug delivery system (drug pump and catheter) is placed under your skin during a surgical procedure.

Medtronic targeted drug delivery offers a number of benefits, including:

  • Effective pain relief1-7
  • Reduced or eliminated use of pain medication4-6
  • Reduced side effects compared to oral medication1,5,8
  • Improved ability to function and participate in activities of daily living4,9
  • Patient satisfaction4,5,9,10

In addition, this treatment:

  • Has been proven to be safe and effective when used as directed
  • Does not involve permanent changes to the spinal cord or nerves
  • Can be adjusted to dispense medication according to your activity level and needs
  • Lets you try the therapy for a short period of time before committing to long-term therapy
  • Is reversible—the therapy can be turned off, or if desired, it can be surgically removed

The implanted pump and catheter are placed under the skin surgically. Surgical complications are possible and include infection, spinal fluid leak, and headache. You should not undergo the implant procedure if you have an active infection at the time scheduled for implant.

Once the infusion system is implanted, device complications may occur, which may require surgery to resolve. Drug overdose or underdose can result because of these complications and have serious and even life-threatening adverse effects. Possible complications include the catheter or pump moving within the body or wearing through the skin. The catheter could leak, tear, kink, or become disconnected. The pump could stop because the battery has run out or because of failure of another part of the infusion system. Additionally, inflammatory mass has been reported at the tip of the catheter, which may lead to complications, including paralysis.

See Important Safety Information for more details. Also, please discuss the benefits and risks of this therapy with your doctor.

On average, the procedure takes about 1 to 3 hours from start to finish. Talk with your doctor about the specifics and duration of your procedure.

Typically, the implant is performed under general anesthesia. However, you may wish to talk with your doctor about other options.

Depending on your doctor’s preference and hospital policy, a 1- to 2-night hospital stay may be recommended.

Usually not. The incision needs to be made where the pump will be implanted to help properly anchor the pump. Proper anchoring helps keep the drug pump in place. This may help minimize your discomfort and speed recovery.

That depends on your specific condition(s) and the results you received from the trial. Your doctor will advise you of the recommended catheter location.

In some cases, you may experience a spinal headache as a result of a needle or catheter being placed in the intrathecal space. A spinal headache is caused when cerebrospinal fluid (the fluid that surrounds the spinal cord) leaks out of the intrathecal space. This headache may correct itself, or the doctor may treat it.

You will begin receiving treatment as soon as your drug pump is filled with medication and the medication is delivered through the catheter to the specific site. However, depending on your medication, it may take several days to weeks before you experience benefits from your medication. During this transition period, your doctor may reduce or eliminate your other medication.

The medication in your pump needs to be refilled every 6 weeks to 6 months, depending on the drug concentration and the amount of pain medication you receive every day. A higher dosage requires more frequent filling. The pump is refilled by a needle injection in your doctor’s office. During these appointments your doctor can adjust your dose of medication to address your pain relief needs.

Yes. After implantation, your doctor can make changes in dosage requirements.

Let your doctor know if you are not receiving adequate relief from your symptoms. The doctor may be able to reprogram the pump to adjust the amount of medication it delivers.

The Medtronic programmable, targeted drug delivery system allows full-body MRI scans under specific conditions. Your drug pump does not need to be emptied prior to MRI exposure. It is important to know that the magnetic field of the MRI scanner will temporarily stop your pump motor and stop drug infusion until the MRI exposure is complete. Your pump should then resume its normal operation. Your doctor will need to make sure your normal infusion has resumed after the MRI procedure.

Yes. The screening test is designed to determine whether the pump will help manage your pain. However, your doctor can surgically remove the system or replace your medication with inactive sterile saline.

The SynchroMed® II drug pump is 3.4" wide and about an inch thick.

Because your pump is placed near the surface of your skin for refill access, on occasion someone might notice a slight bump if you are wearing fitted clothes. However, depending on your size and shape, where the pump is implanted, and the size of your pump, it may not show under your clothes at all.

Some doctors choose to use an opioid medication in the drug pump. There are risks associated with the use of any opioid pain medication. For more details, see opioid pain medication questions and answers.

References

  1. Smith TJ, Staats PS, Deer T, et al. Randomized Clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20:4040-4049.
  2. Raphael JH, Duarte RV, Southall JL, Nightingale P, Kitas GD. Randomised, double-blind controlled trial by dose reduction of implanted intrathecal morphine delivery in chronic non-cancer pain. BMJ Open. 2013;3(7):e003061.
  3. Rauck RL, Wallace MS, Leong MS, et al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006;31:393-406.
  4. Deer T, Chapple I, Classen A, et al. Intrathecal drug delivery for treatment of chronic low back pain: report from the National Outcomes Registry for Low Back Pain. Pain Med. 2004;5:6-13.
  5. Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of lowdose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13:1304-1313.
  6. Atli A, Theodore BR, Turk DC, Loeser JD. Intrathecal opioid therapy for chronic nonmalignant pain: a retrospective cohort study with 3-year follow-up. Pain Med. 2010;11:1010-1016.
  7. Ellis DJ, Dissanayake S, McGuire D, et al. Continuous intrathecal infusion of ziconotide for treatment of chronic malignant and nonmalignant pain over 12 months: a prospective, open-label study. Neuromodulation. 2008;11:40-49.
  8. Ruan X. Drug-related side effects of long-term intrathecal morphine therapy. Pain Physician. 2007;10:357-366.
  9. Roberts LJ, Finch PM, Goucke CR, Price LM. Outcome of intrathecal opioids in chronic non-cancer pain. Eur J Pain. 2001;5:353-361.
  10. Winkelmüller M, Winkelmüller W. Long-term effects of continuous intrathecal opioid treatment in chronic pain of nonmalignant etiology. J Neurosurg. 1996;85:458-67.