Clinical UM Guideline

This document addresses the use of implantable infusion pumps, intended to provide long-term, continuous, or intermittent drug infusion. The document does not address implantable reservoirs or implantable infusion systems without a pump.

Medically Necessary:

Implantable infusion pumps are considered medically necessary when used to deliver drugs for the treatment of:

1. Primary liver cancer (intrahepatic artery injection of chemotherapeutic agents); or
2. Metastatic colorectal cancer where metastases are limited to the liver (intrahepatic artery injection of chemotherapeutic agents); or
3. Severe, refractory spasticity of cerebral or spinal cord origin in individuals who are unresponsive to or cannot tolerate oral baclofen (Lioresal^®) therapy (intrathecal injection of baclofen); or
4. Pulmonary arterial hypertension for individuals that have previously been receiving the drug treprostinil (Remodulin^®) via an external infusion pump; or
5. Severe, chronic, intractable pain when a successful trial of opioid or nonopioid analgesics by the same route of administration as the planned treatment (for example, intravenous, intrathecal, or epidural injection).

Note: A successful trial is defined as greater than 50% reduction in pain.

Note: When an implantable/intrathecal infusion pump is determined to be medically necessary, the supplies necessary for the proper use of the pump are considered medically necessary.

Replacement of an implantable/intrathecal infusion pump (which may also involve upgrading to the most current technology) is considered medically necessary when the device is not functioning or when a built-in system in the pump provides notification of an impending failure.

Not Medically Necessary:

Replacement or upgrades of an implantable/intrathecal infusion pump is considered not medically necessary when requested for convenience or to upgrade to newer technology when the current components remain functional.

Implantable infusion pumps are considered not medically necessary for the infusion of heparins for thromboembolic disease or antibiotics for osteomyelitis.

All other uses of implantable infusion pumps, including fully implantable insulin pumps, are considered not medically necessary.

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:
For the procedure codes listed below for all other diagnoses not specified as not medically necessary

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met, for the following diagnoses, or for situations designated in the Clinical Indications section as not medically necessary.

Implantable Infusion Pumps

Implantable infusion pump use for the delivery of intrathecal (intraspinal) opiates is based on the existence of opioid (narcotic) receptors on the spinal cord to achieve “selective spinal analgesia” (pain relief). Pumps provide for the long-term delivery of opioid (narcotic) medication in the management of malignant (cancer) pain and nonmalignant (non-cancer) pain. Examples of appropriate nonmalignant pain syndromes which may be treated with implantable pumps include “failed back surgery”, chronic arachnoiditis, visceral pain syndromes, post herpetic neuralgia, phantom limb pain, spinal cord injuries, peripheral neuropathies and reflex sympathetic dystrophy. A successful temporary trial of spinal opiates is required both to evaluate analgesic responsiveness and to increase the long-term success of the procedure. Individuals must be closely monitored as conversion from high dose oral or systemic opioids to spinally administered opioids will sometimes result in withdrawal symptoms.

Treatment with this therapy should remain a last resort, used only after all other appropriate therapies have failed. A permanently implantable drug-infusion system is not usually appropriate when life expectancy is 3 months or less; for such individuals, external drug infusion systems can appropriately provide spinal analgesia and comparable pain relief.

The implantable infusion pump (IIP) is a drug delivery system that provides continuous infusion of an agent at a constant and precise rate. The purpose of an IIP is to deliver therapeutic levels of a drug directly to a target organ or compartment. It is frequently used to deliver chemotherapy directly to the hepatic artery or superior vena cava.

An IIP is surgically placed in a subcutaneous pocket under the infraclavicular fossa or in the abdominal wall and a catheter is threaded into the desired position. A drug is infused over an extended period of time. The drug reservoir may be refilled as needed by an external needle injection through a self-sealing septum in the IIP. Bacteriostatic water or physiological saline is often used to dilute therapeutic drugs. A heparinized saline solution may also be used during an interruption of drug therapy to maintain catheter patency.

There is a range of totally implanted catheters with implanted reservoirs and manual pumps as well as totally implanted catheters with implanted infusion pumps. Implantable infusion pumps are available in either programmable or non-programmable models, depending on the type of medication delivery required. Programmable pumps are for flexible medication delivery as dose titration and regulation will vary due to the dynamic nature of the individual. Programmable designs facilitate flexible dosing options and precise dose titration over time.

An example of a flexible medication delivery pump is the SynchroMed^® electronic pump, manufactured by Medtronic Inc. (Minneapolis, MN, USA). This pump contains a collapsible reservoir that can be filled with 10 to 18 ml of liquid medication and a peristaltic pump that pushes the medication through a bacteriostatic filter and catheter into the spinal canal. The SynchroMed II Infusion system is indicated to deliver prescribed medication for the treatment of chronic pain, severe chronic pain and severe spasticity, respectively. The infusion system has a battery life of 5-7 years with a maximum shut-down design to ensure that the pump provides proper administration of intrathecal therapy. The pump has a built in elective replacement indicator (ERI), this alarm sounds when the pump is nearing the end of service (EOS). The pump will no longer operate 90 days after the alarm has sounded, a pump replacement is recommended to avoid interruption in service and risk of withdrawal of baclofen. The U. S. Food and Drug Administration (FDA) issued a Class I recall in September 2011 due to the potential for reduction of battery performance in the SynchroMed II pump. Codman & Shurtleff, Inc. (Raynham, MA), manufacturer of Medstream™ Programmable Infusion System received FDA premarket supplement for the implantable infusion pump and catheter system for use with baclofen in the treatment of severe spasticity.

Medtronic Inc. (Minneapolis, MN) and United Therapeutics Corp. (Research Triangle Park, NC) received FDA approval for the Implantable System for Remodulin^®. The system is comprised of the SynchroMed II Pump programmable implantable drug delivery system and a newly developed intravascular catheter to deliver Remodulin intravenously for adults with pulmonary arterial hypertension (Class I, II, and III) who were receiving Remodulin via continuous intravenous infusion with an external infusion pump. The FDA approval was based on data reported from the DellVery for Pulmonary Arterial Hypertension (PAH) clinical study (NCT01321073), a prospective, single-arm, nonrandomized, open-label multicenter study, by Waxman and colleagues (2017). The trial enrolled 64 adults with PAH (World Health Organization group 1); 4 exited the study prior to device implantation, and the remaining 60 participants had successful implant procedures. The study showed the implantable intravascular delivery system was an effective option for delivery of treprostinil (Remodulin), with a low rate of catheter-related complications, and a high rate of participant satisfaction. Clinically significant implant procedure-related complications included one pneumothorax, two infections unrelated to catheter placement, and one episode of atrial fibrillation. Three catheter dislocations in 2 participants occurred early in the trial; catheters were removed and replaced via surgical procedure. In conclusion:

Procedural success was demonstrated: 100% of the attempted implant procedures were successfully completed. PAH therapy, anticoagulation, and other comorbidities were safely managed during the surgical procedure and postoperatively. The implant procedure was successfully performed with a low complication rate by clinicians with diverse range of specialty training.

Non-programmable pumps are for fixed rate medication delivery when the dosage is expected to be stable. Possible routes of administration include intravenous, intrahepatic, intra-arterial, subcutaneous, intraperitoneal, intrathecal, epidural, and intraventricular.

The role of opioid therapy in treatment of pain is well established in the medical literature. Individuals who have proven unresponsive to less invasive medical therapy and who require large doses of opioids may be candidates for an implantable delivery system that permits intrathecal administration. This system delivers the opioid directly to the receptors in the spinal cord, allowing smaller doses to be used and thereby minimizing side effects. A preliminary trial of an intraspinal opioid drug is administered using a temporary intrathecal/epidural catheter (continuous infusion or bolus injection) to substantiate adequate pain relief and acceptable degree of side effects. This position is supported by multiple case control studies.

In 2017, the North American Spine Society (NASS) published coverage policy recommendations addressing the use of spinal intrathecal drug delivery systems (IDDS) for the treatment of pain and spasticity caused by spinal pathology. The use of IDDS to treat pain and spasticity is established in the literature. IDDS are typically considered when other therapies have failed. The NASS clinical indications include the following recommendations:

Nonmalignant Pain:

1. Severe chronic pain caused by verifiable spinal pathology with clinical manifestations known to be associated with the underlying condition.
2. Patient has failed or could not tolerate other treatment methods including but not limited to nonopioid medications, physical therapy and appropriate interventional (nonsurgical) treatments.
3. Patient has demonstrated compliance with previous attempts to treat their condition.
4. Demonstrable improvement of pain and function with systemic opiates and development of intolerable side effects, tolerance, or hyperalgesia.
5. Psychosocial evaluation to rule out active drug and alcohol disorders and psychiatric conditions.
6. Patient is not a candidate for other surgical interventions.
7. Patient agrees to a 50% reduction in systemic opiates prior to undergoing an IT opiate trial. While undergoing the IT trial there is ≥50% decrease in pain with a concomitant increase in function.
8. Patients who have had a successful trial agree to continue to taper their systemic opioids.
9. Candidates have undergone a trial of IT treatment with at least 50% improvement in symptoms.

Spasticity:

IDDS are indicated for the treatment of severe spasticity when either of the following conditions are met:

1. Patients with severe spasticity who either fail to respond to oral baclofen or develop intolerable side-effects to the medication.
2. Patient has a baseline average Ashworth score of at least 3 and a Spasm Frequency score of at least 2 and demonstrates at least a 2-point reduction in the Ashworth or Spasm Frequency score for 4 hours following an intrathecal trial bolus of baclofen.

The use of continuous chemotherapy infusion treatment has been studied for individuals with primary hepatic cancer and metastatic colorectal cancer to the liver. This method of chemotherapy infusion has been found to improve medical outcomes in select individuals where continuous chemotherapy is believed to be appropriate. The evidence supporting this conclusion includes multiple randomized controlled trials. Prospective randomized trials of individuals with unresectable liver disease have shown that compared to conventional systemic therapy, hepatic artery infusion is associated with an increased tumor response rate.

In 2023, Ho and colleagues completed a meta-analysis to examine if adjuvant hepatic artery infusion of chemotherapy improved outcomes for individuals with hepatocellular carcinoma (HCC) following liver resection. The primary outcomes measured were overall survival and disease-free survival. The analysis included 11 studies (2 randomized controlled trials and 9 retrospective studies) which included 1290 individuals; 513 individuals were treated with liver resection and adjuvant hepatic artery infusion chemotherapy (HAIC), and 777 individuals were treated with liver resection only. The results demonstrated that adjuvant HAIC improved overall survival rate (p<0.01) and disease-free survival (p<0.01) respectively. A sub-analysis showed that individuals with portal vein invasion or microvascular invasion benefit from adjuvant HAIC in overall survival (p<0.01 and p=0.0373, respectively), and disease-free survival (p<0.01 and p=0.0125, respectively). Adjuvant HAIC with the oxaliplatin-based approach improved overall survival (p=0.02 and p<0.01, respectively). The authors concluded that postoperative adjuvant HAIC in individuals with hepatocellular carcinoma with portal vein invasion or microvascular invasion is clinically beneficial, however, it is not clear whether HAIC may improve the survival outcome in all individuals with hepatocellular carcinoma after liver resection.

Several studies have evaluated interventions that combine radiotherapy and concomitant intra-arterial cisplatin, otherwise known as RADPLAT for treatment of head and neck cancer. Ackerstaff and colleagues (2009) reported results from a randomized multicenter study that examined 17 quality-of-life scale assessments after treatment with radiotherapy with intravenous or intra-arterial cisplatin. A total of 207 participants with advanced head and neck cancer were included in the study. Quality-of-life symptoms reported between both groups were similar; the only statistically significant difference reported between groups was the nausea/vomiting scale at 7 weeks, at which time the rate of symptoms was higher in the intravenous compared to the intra-arterial population. Current evidence has not demonstrated a clear advantage of intra-arterial chemotherapy delivery via an intra-arterial catheter compared to intravenous chemotherapy in combination with radiotherapy for individuals with advanced head and neck cancer (Rasch, 2010). Clinical trials are underway to explore the use of intra-arterial chemotherapy in locally advanced squamous cell carcinoma.

Implantable pumps for delivery of medication to the intrathecal space have been developed as an alternative to chronic systemic administration for the treatment of spasticity of cerebral or spinal origin. These pumps have been demonstrated in numerous randomized controlled trials to reduce adverse effects such as tolerance, dependency, and neurotoxicity.

The use of implantable pumps for infusion of antithrombotic medications for thromboembolic disease, or for the infusion of antibiotics for osteomyelitis, has not been demonstrated to provide any additional improvement in net health outcomes above standard care with bolus or subcutaneous drug administrations. This therapy does not prevent the occurrence of complications or morbidity, nor does it significantly relieve pain over other less invasive treatment methods. The risks involved in the implantation and maintenance of implantable infusion pumps for these conditions is not outweighed by any potential benefits. The evidence supporting this conclusion includes multiple case series studies.

Fully Implantable Insulin Pumps

The Medtronic MiniMed^® 2017, an implantable insulin pump was the most recent device to be evaluated in a clinical trial. At the time of this writing, no implantable insulin pumps have received FDA approval for marketing.

Fully implantable insulin pumps are designed to deliver insulin via intraperitoneal or intravenous routes in a programmed and controlled manner to diabetics. However, these pumps have been associated with a high incidence of device malfunction related to catheter obstruction, among other malfunctions. Newer devices are under development that are expected to drastically reduce the problem of catheter obstruction. With additional refinements underway, implantable insulin pumps may eventually prove beneficial in the treatment of insulin dependent diabetics. To show benefit, however, additional long-term randomized prospective studies are needed.

Intrathecal Drug Delivery System (IDDS)

The intrathecal (IT) catheter is inserted through a needle into the intraspinal space, usually at the lumbar or thoracic level. The other end of the catheter is connected to the pump and then filled with medication. The choice of IT pump depends on the indications for intraspinal therapy, the need for bolus versus continuous infusion, the available support services, cost to the individual, and the individual’s general medical condition, ambulatory status and life expectancy.

External programming is used to set the dosage, rate and timing via telemetry to the pump. The pump needs to be refilled every 4 to 8 weeks by percutaneous injection, depending on flow rate, and trained medical, nursing or technical staff must perform the refilling process.

Bacteriostatic: An agent that inhibits the growth or multiplication of bacteria.

Bolus: A large dose of a drug given intravenously for the purpose of rapidly achieving the needed therapeutic concentration in the bloodstream.

Hepatic colorectal metastases: Colorectal cancer that has spread from its site of origin to the liver.

Infraclavicular fossa: A triangular depression bounded by the clavicle and the adjacent borders of the deltoid and pectoralis major muscles.

Intra-arterial therapies (IAT): A group of cancer treatments that deliver concentrated doses of cancer-killing medicine directly to the affected area; they may be used to occlude arterial blood supply to a tumor, to deliver a high local concentration of chemotherapy, and/or to deliver tumor-selective radiation.

Intrathecal space: The space between the spinal cord and the surrounding membrane (dura mater), which is filled with cerebrospinal fluid. Osteomyelitis: Inflammation of the bone due to infection.

Parenteral: Is a route of administration by injection as in subcutaneous, intramuscular, or intravenous.

Primary liver cancer: A cancer that originates within liver cells, as opposed to having spread from other organs.

Peer Reviewed Publications:

1. Ackerstaff AH, Balm AJ, Rasch CR, et al. First-year quality of life assessment of an intra-arterial (RADPLAT) versus intravenous chemoradiation phase III trial. Head Neck. 2009; 31(1):77-84.
2. Albright AL, Gilmartin R, Swift D, et al. Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg. 2003; 98(2):291-295.
3. Albright AL. Intrathecal baclofen in cerebral palsy movement disorders. J Child Neurol. 1996; 11(Suppl 1):S29-S35.
4. Anderson V, Burchiel KJ. A prospective study of long-term intrathecal morphine in the management of chronic nonmalignant pain. Neurosurgery. 1999; 44(2):289-300.
5. Awaad Y, Tayem H, Munoz S, et al. Functional assessment following intrathecal baclofen therapy in children with spastic cerebral palsy. J Child Neurol. 2003; 18(1):26-34.
6. Bloomgarden ZT. Treatment issues in type 1 diabetes. Diabetes Care. 2002; 25(1):230-236.
7. Bourge RC, Waxman AB, Gomberg-Maitland M, et al. Treprostinil administered to treat pulmonary arterial hypertension using a fully implantable programmable intravascular delivery system: Results of the DelIVery for PAH trial. Chest. 2016; 150(1):27-34.
8. Carek PJ, Dickerson LM, Sack JL. Diagnosis and management of osteomyelitis. Am Fam Phys. 2001; 63(12):2413-2420.
9. Damascelli B, Patelli G, Frigerio LF, et al. First clinical experience with a high-capacity implantable infusion pump for continuous intravenous chemotherapy. Cardiovasc Intervent Radiol. 1999; 22(1):37-43.
10. Gilmer-Hill HS, Boggan JE, Smith KA, Wagner FC Jr. Intrathecal morphine delivered via subcutaneous pump for intractable cancer pain: a review of the literature. Surg Neurol. 1999; 51(1):12-15.
11. Gooch JL, Oberg WA, Grams B, et al. Care provider assessment of intrathecal baclofen in children. Dev Med Child Neurol. 2004; 46(8):548-552.
12. Hartkamp A, Van Boxtel AD, Zonnenberg BA, Witteveen PO. Totally implantable venous access devices: evaluation of complications and a prospective comparative study of two different port systems. Neth J Med. 2000; 57(6):215-223.
13. Hoebers FJ, Pluim D, Verheij M, et al. Prediction of treatment outcomes by cisplatin-DNA adduct formation in patients with stage III/IV head and neck squamous cell carcinoma, treated by concurrent cisplatin-radiation (RADPLAT). Int J Cancer. 2006; 119:750-756.
14. Hu L, Zheng Y, Lin J, et al. Does adjuvant hepatic artery infusion chemotherapy improve patient outcomes for hepatocellular carcinoma following liver resection? A meta-analysis. World J Surg Oncol. 2023; 21(1):121.
15. Jeandidier N, Boullu S, Busch-Brafin MS, et al. Comparison of antigenicity of Hoechst 21PH insulin using either implantable intraperitoneal pump or subcutaneous external pump infusion in type 1 diabetic patients. Diabetes Care. 2002; 25(1):84-88.
16. Kemeny N, Huang Y, Cohen AM, et al. Hepatic arterial infusion of chemotherapy after resection of hepatic metastases from colorectal cancer. NEJM. 1999:341(27):2039-2048.
17. Kessler L, Tritschler S, Bohbot A, et al. Macrophage activation in type 1 diabetic patients with catheter obstruction during peritoneal insulin delivery with an implantable pump. Diabetes Care. 2001; 24(2):302-307.
18. Krach LE, Kriel RL, Gilmartin RC, et al. Hip status in cerebral palsy after one year of continuous intrathecal baclofen infusion. Pediatr Neurol. 2004; 30(3):163-168.
19. Kraus T1, Gegenleitner K2, Svehlik M2, et al. Long-term therapy with intrathecal baclofen improves quality of life in children with severe spastic cerebral palsy. Eur J Paediatr Neurol. 2017; 21(3):565-569.
20. Metz L. Multiple sclerosis: symptomatic therapies. Semin Neurol. 1998; 18(3):389-395.
21. Pak LM, Kemeny NE, Capanu M, et al. Prospective phase II trial of combination hepatic artery infusion and systemic chemotherapy for unresectable colorectal liver metastases: Long term results and curative potential. J Surg Oncol. 2018; 117(4):634-643.
22. Penn RD, Paice JA. Chronic intrathecal morphine for intractable pain. J Neurosurg 1987; 67:182-186.
23. Pohl M, Rockstroh G, Ruckriem S, et al. Time course of the effect of a bolus dose of intrathecal baclofen on severe cerebral spasticity. J Neurol. 2003; 250(10):1195-1200.
24. Prager J, Jacobs M. Evaluation of patients for implantable pain modalities: medical and behavioral assessment. Clin J Pain. 2001; 17(3):206-214.
25. Rasch CR, Hauptmann M, Schornagel J, et al. Intra-arterial versus intravenous chemoradiation for advanced head and neck cancer: Results of a randomized phase 3 trial. Cancer. 2010; 116(9):2159-2165.
26. Sadahiro S, Suzuki T, Ishikawa K, et al. Prophylactic hepatic arterial infusion chemotherapy for the prevention of liver metastasis in patients with colon carcinoma: a randomized control trial. Cancer. 2004:100(3):590-597.
27. Saudek CD, Duckworth WC, Giobbie-Hurder A, et al. Implantable insulin pumps vs. multiple dose insulin for non-insulin-dependent diabetes mellitus: a randomized clinical trial. Dept of Veterans Affairs Implantable Insulin Pump Study Group. JAMA. 1996; 276(16):1322-1327.
28. Skitzki JJ, Chang AE. Hepatic artery chemotherapy for colorectal liver metastases: technical considerations and review of clinical trials. Surg Oncol. 2002; 11(3):123-135.
29. Smith TJ, Staats PS, Deer T, et al. Implantable Drug Delivery Systems Study Group. 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(19):4040-4049.
30. Taricco M, Adone R, Pagliacci C, Telaro E. Pharmacological interventions for spasticity following spinal cord injury. Cochrane Database Syst Rev. 2000; (2):CD001131.
31. Waxman AB, McElderry HT, Gomberg-Maitland M, et al. Totally implantable IV treprostinil therapy in pulmonary hypertension assessment of the implantation procedure. Chest. 2017; 152(6):1128-1134.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Society of Anesthesiologists, Inc. Practice guidelines for chronic pain management: An updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2010; 112(4):810-833.
2. Australian Safety and Efficacy Register of New Interventional Procedures; Surgical Implantable Spinal Infusion Devices for Chronic Pain and Spasticity. 2003; 1-46.
3. Centers for Medicare and Medicaid Services. National Coverage Determination for Infusion Pumps. NCD #280.14. Effective December 17, 2004. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=223&ncdver=2&SearchType=Advanced&CoverageSelection=National&NCSelection=NCA%7cCAL%7cNCD%7cMEDCAC%7cTA%7cMCD&KeyWord=infusion&KeyWordLookUp=Doc&KeyWordSearchType=Exact&kq=true&bc=IAAAACAAAAAAAA%3d%3d&. Accessed on June 20, 2023.
4. Deer TR, Hayek SM, Pope JE, et al. The Polyanalgesic Consensus Conference (PACC): Recommendations for Trialing of Intrathecal Drug Delivery Infusion Therapy. Neuromodulation. 2017; 20(2):133-154.
5. NASS Coverage Committee, Glaser J, Kreiner S, et al. The North American Spine Society. NASS coverage policy recommendations on intrathecal drug delivery systems. Updated March 2017. Available at: https://www.spine.org/coverage. Accessed on June 20 , 2023.
6. NCCN Clinical Practice Guideline in Oncology^™ (NCCN). © 2023 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on June 20, 2023.
   • Adult Cancer Pain (V.1.2023). Revised March  7, 2023.
   • Biliary Tract Cancers (V.2.2023). Effective March 10,  2023.
   • Colon Cancer (V.2.2023). Revised April 25, 2023.
   • Hepatocellular Carcinoma (V.1.2023). Effective March 10, 2023.
   • Rectal Cancer (V.3.2023). Revised May 26, 2023.
7. U.S. Food and Drug Administration (FDA). Medical Devices. Implantable System for Remodulin - P140032. December 22, 2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140032. Accessed on June 20, 2023.
8.  U.S. Food and Drug Administration (FDA). Medical Devices. Intera 3000 Hepatic Artery Infusion Pump- P890055. March 11, 1996. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P890055. Accessed on June 21, 2023.
9. U.S. Food and Drug Administration (FDA). Medical Devices. Premarket Approval (PMA) P860004 S380. December 21, 2021. Medtronic^® SynchroMed^™ Infusion System Ascenda Intrathecal Catheters. Available at: Premarket Approval - PMA (fda.gov). Accessed on June 20, 2023.

1. National Cancer Institute (NCI). Available at: http://www.cancer.gov/types. Accessed on June 20, 2023.
   • Adult primary liver cancer treatment (PDQ^®). Updated  January 20, 2023.
   • Colon cancer treatment (PDQ). Updated  May 11, 2023.

Drug Infusion Pumps
HAI
Hepatic Arterial Infusion
Implantable Infusion Pumps
Intrathecal Baclofen for Spasticity
Intrathecal Drug Delivery System
Venous Access Device, Implantable

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.