Intrathecal Drug Delivery

• Cost-Effectiveness of Long-Term Intrathecal Morphine Therapy for Pain Associated with Failed Back Surgery Syndrome

This decision analytic study was conducted using computer simulation to project the outcomes in a simulated cohort of patients whose treatment for back surgery had failed. The objective of the study was to estimate the direct cost of intrathecal morphine therapy (IMT) delivered via an implantable pump relative to alternative therapy (medical management) over a 60-month course of treatment.

de Lissovoy G, Brown R, Halpern M, Hassenbusch S, Ross E.
Clinical Therapeutics, 1997

• Inflammatory Masses Associated with Intrathecal Drug Infusion: A Review of Preclinical Evidence and Human Data

This article seeks to synthesize current clinical and preclinical data to formulate hypotheses about the etiology of catheter-tip masses.

Yaksh T, Hassenbusch S, Burchiel K, Hildebrand K, Page L, Coffey R.
Pain Medicine, 2002

• Inflammatory Mass Lesions Associated with Intrathecal Drug Infusion Catheters: Report and Observations on 41 Patients

This article evaluates reports describing inflammatory mass lesions at the tip of intraspinal drug administration catheters. It assesses the number of patients reported with this condition and determines whether data support hypotheses that have been put forth regarding the cause of these lesions.

Coffey R, Burchiel K.
Neurosurgery, 2002

• Intrathecal Drug Delivery for Chronic Pain Literature Summary

The intent of this summary is to present data from published scientific literature relating to clinical and cost-effectiveness of intrathecal drugdelivery (IDD) for chronic, intractable pain.

This Literature Review was authored by Douglas E. Busby, MD. Dr. Busby, a former Medicare contractor medical director, is a Medtronic consultant.

Medtronic Inc., 2008

• Intrathecal Drug Delivery for Treatment of Chronic Low Back Pain: Report from the National Outcomes Registry for Low Back Pain

This paper obtains data on demographics, clinical practices, and long-term outcomes for patients with chronic low back pain treated with implantable drug-delivery systems.

Deer T, Chapple I, Classen A, Javery K, Stoker V, Tonder L, Burchiel K.
Pain Medicine, 2004

• Management of Intrathecal Catheter-Tip Inflammatory Masses: A Consensus Statement

In this article, physicians discuss their recommendations for the detection, treatment, mitigation, and prevention of catheter-tip inflammatory masses.

Hassenbusch S, Burchiel K, Coffey R, Cousins M, Deer T, Hahn M, Du Pen S, Follett K, Krames E, Rogers J, Sagher O, Staats P, Wallace M, Willis KD.
Pain Medicine, 2002

• Mortality Associated with Implantation and Management of Intrathecal Opioid Drug Infusion Systems to Treat Noncancer Pain

In 2006, Medtronic, Inc. and a team of noted experts investigated what might have caused the deaths of three 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.

Coffey, Robert J. M.D.; Owens, Mary L. M.D.; Broste, Steven K. M.S.; Dubois, Michel Y. M.D.; Ferrante, F Michael M.D.; Schultz, David M. M.D.; Stearns, Lisa J. M.D.; Turner, Michael S. M.D.

• Prevention and Management of Intrathecal Drug Delivery and Spinal Cord Stimulation System Infections

Device-related infection is the most common, potentially reducible, serious adverse event associated with IDD or SCS devices. This article discusses practices and procedures that can help prevent and minimize infections related to IDD therapies.

Follett K, Boortz-Marx R, Drake J, DuPen S, Schneider S, Turner M, Coffey R. Anesthesiology, 2004

• Prevention of Intrathecal Drug Delivery Catheter-Related Complications

In this article, a group of physicians experienced in the management of implantable intrathecal drug delivery systems reviews surgical practices and principles associated with low catheter-related complication rates.

Follett K, Burchiel K, Deer T, DuPen S, Prager J, Turner M, Coffey R. Neuromodulation, 2003

• 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

This randomized trial discusses whether intrathecal drug delivery systems improve clinical success in reducing pain and relieve common drug toxicity problems in patients with refractory cancer pain.

Thomas J. Smith, et al.
Journal of Clinical Oncology, 2003

• Treatment of Chronic Pain by Using Intrathecal Drug Therapy Compared with Conventional Pain Therapies: A Cost-effectiveness Analysis

This study compares the cost-effectiveness of intrathecal drug intervention with that of conventional pain interventions in patients suffering from chronic low back pain caused by failed back syndrome.

Kumar K, Hunter G, Demeria D.
Journal of Neurosurgery 2002

• SynchroMed EL & II Pump Corrosion from Nonindicated Drug Formulations

Medtronic has confirmed through returned product analysis that the use of nonindicated drug formulations can compromise the performance of the SynchroMed II and SynchroMed EL infusion systems. This paper discusses the mechanism by which nonindicated drug formations can cause corrosion to the pumps internal components, resulting in permanent motor stalls and therapy cessation.

• SynchroMed EL & II Intrathecal Catheter Distal End Occlusions

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.