Medtronic Drug Delivery Therapy for Cancer Pain
Template News Release for Local Use
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Hospital Contact
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Cancer Patients at <XXX Hospital> Find Relief from Difficult-to-Treat Cancer
Pain with Drug Delivery Therapy
XXX – DATE – About 50 percent of all cancer patients and 70 percent of patients
with advanced cancer have pain,1 which has been described as the most
important and most feared symptom they experience.1,2 At <XXX Hospital>,
cancer patients who suffer from pain that is not well managed with conventional
pain treatments have another effective pain management option available. Drug
delivery therapy with the Medtronic SynchroMed® II system, a proven pain
management treatment, has helped many cancer patients to achieve significant
pain relief with less medication3-7 and fewer side effects than conventional pain
treatments.3-9
Drug delivery therapy uses an implantable drug infusion system to send pain
medication directly into the area where fluid flows around the spinal cord, which
is also known as the intrathecal space. Unlike conventional analgesic painrelievers (e.g., aspirin, ibuprofen and narcotics), drug delivery therapy releases a
pain-relieving medication directly to the spinal cord where pain signals travel,
interrupting the pain signals before they reach the brain.10 People who have
success with drug delivery therapy report benefits that include: a significant
reduction in pain; improved ability to function and participate in the activities of
daily living; lower medication doses compared with oral medications (e.g.,
approximately 1/300 of an oral morphine dose), which may help to minimize the
side effects that often accompany other treatments; and, less oral pain
medication(s).10-18
“Cancer pain is very often associated with a decreased quality of life, including
psychological distress, disturbed sleep, reduced appetite and impairments in
social functioning,” said <physician name, title, institution>. “Intrathecal drug
delivery provides pain relief in patients with a small fraction of the medication
needed if taken orally and provides comfort when it’s most important.”
At <XXX Hospital>, <patient name> recently received drug delivery therapy with
Medtronic’s SynchroMed II system. <Insert patient’s medical history and experience
with the system.>
The Medtronic SynchroMed II drug delivery therapy system consists of a drug
pump that is placed under the skin of the abdomen and a catheter that connects
to the pump and dispenses medicine to the intrathecal space of the spine. Using a
handheld programmer, a physician can adjust the medication dosage for drug
delivery to optimize the therapy of each patient, and a handheld patient control
device called the Personal Therapy Manager (myPTM®) allows patients to give
themselves an extra dose of medication in response to intermittent pain.17 The
system also includes software to verify that enough time has elapsed between
patient-activated doses and a patient diary to track key information, such as
delivery times and self-pain ratings that a physician can use to adjust dosages.
Since the first Medtronic implantable drug pump was approved for the
treatment of chronic pain 20 years ago, thousands of people have received
Medtronic drug delivery therapy to manage cancer pain as well as other
conditions that include: chronic back and leg pain, Complex Regional Pain
Syndrome (CRPS) and painful neuropathy.20
<Insert short paragraph about hospital’s expertise treating cancer and related pain.
Include regional statistics as available.>
“Despite national and global efforts designed to improve cancer treatment and
pain care, many patients with cancer continue to experience unnecessarily high
levels of unrelieved pain,” said <physician name, title, institution>. “Intrathecal
drug delivery therapy can help create better days for patients who are not
receiving the relief they need and reduce unnecessary suffering through their
treatment.”
People interested in additional information should contact <insert appropriate
phone and/or web site contact information.>
About <XXX Hospital>
<Add boilerplate information.>
References
1. Portenoy RK. Cancer pain epidemiology and syndromes. Cancer
1989;63:2298e2307.
2. Bonica J. Cancer pain. In: Bonica J, ed. The management of pain, vol.1, 2nd ed.
Philadelphia: Lea and Febiger, 1990;400–414.
3. Kumar K, Taylor RS, Jacques, et. al. Spinal cord stimulation versus
conventional medical management for neuropathic pain: a multicentre
randomized controlled trial in patients with failed back surgery syndrome.
Pain. 2007;132:179-188.
4. Burchiel K, Anderson V, et al. Prospective, Multicenter Study of Spinal Cord
Stimulation for Relief of Chronic Back and Extremity Pain. Spine 1996;21:27862794.
5. Lamer TJ. Treatment of cancer-related pain: When orally administered
medications fail. Mayo Clinical Proc 1994;69:473-80.
6. Levy, R. Implanted Drug Delivery Systems for Control of Chronic Pain.
Chapter 19 of Neurosurgical Management of Pain. New York, NY: SpringerVerlag; 1997.
7. Link: http://www.medtronic.com/IN/health/pain_treatment_intra.html.
Accessed: January 11, 2011.
8. Paice J. J Pain Symptom Manage 1996; 11:71-80.
9. Winkelmuller M. J Neurosurg 1996; 85:458-467.
10. Doleys DM, Brown JL, Ness T. Multidimensional outcomes analysis of
intrathecal, oral opioid and behavioral functional restoration therapy for
failed back surgery syndrome: a retrospective study with 4 years’ follow-up.
Neuromodulation. 2006;9:270-283.
11. 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.
12. Roberts LJ, Finch PM, Goucke CR, Price LM. Outcome of intrathecal opioids
in chronic non-cancer pain. Eur J Pain. 2001;5:353-361.
13. Brogan SE. Intrathecal therapy for the management of cancer pain. Curr Pain
Headache Rep. 2006;10:254-259.
14. Gerber HR. Intrathecal morphine for chronic benign pain. Best Pract Res Clin
Anaesthesiol. 2003;17:429-442.
15. Nance P, Meythaler J. Intrathecal drug therapy. Phys Med Rehabil Clin N
Am. 1999;10:385-401, viii-ix.
16. Ruan X. Drug-related side effects of long-term intrathecal morphine therapy.
Pain Physician. 2007;10:357-366.
17. Smith TJ, Swainey C, Coyne PJ. Pain management, including intrathecal
pumps. Curr Pain Headache Rep. 2005;9:243-248.
18. Winkelmüller M, Winkelmüller W. Long-term effects of continuous
intrathecal opioid treatment of chronic pain of nonmalignant etiology. J
Neurosurg. 1996;85:458-467.
19. Link: http://www.medtronic.com/your-health/cancer/device/what-is-drugpump-therapy/index.htm. Accessed: January 12, 2011.
20. Link: http://www.medtronic.com/our-therapies/index.htm. Accessed: January
12, 2011.
Important Safety Information
SynchroMed® II Drug Infusion System Brief Summary:
Product technical manuals and the appropriate drug labeling must be
reviewed prior to use for detailed disclosure.
Indications:
US: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free
morphine sulfate sterile solution in the treatment of chronic intractable pain,
chronic intrathecal infusion of preservative-free ziconotide sterile solution for the
management of severe chronic pain, and chronic intrathecal infusion of
Lioresal™ Intrathecal (baclofen injection) for the management of severe
spasticity; chronic intravascular infusion of floxuridine (FUDR) or methotrexate
for the treatment of primary or metastatic cancer. Outside of US: Chronic
infusion of drugs or fluids tested as compatible and listed in the product
labeling.
Contraindications:
Infection; implant depth greater than 2.5 cm below skin; insufficient body size;
spinal anomalies; drugs with preservatives, drug contraindications, drug
formulations with pH ≤3, use of catheter access port (CAP) kit for refills or of
refill kit for catheter access, blood sampling through CAP in vascular
applications, use of Personal Therapy Manager to administer opioid to opioidnaïve patients or to administer ziconotide.
Warnings:
Non-indicated formulations may contain neurotoxic preservatives,
antimicrobials, or antioxidants, or may be incompatible with and damage the
system. Failure to comply with all product instructions, including use of drugs
or fluids not indicated for use with system, or of questionable sterility or
quality, or use of non-Medtronic components or inappropriate kits, can result
in improper use, technical errors, increased risks to patient, tissue damage,
damage to the system requiring revision or replacement, and/or change in
therapy, and may result in additional surgical procedures, a return of
underlying symptoms, and/or a clinically significant or fatal drug under- or
overdose. Refer to appropriate drug labeling for indications, contraindications,
warnings, precautions, dosage and administration information, screening
procedures and underdose and overdose symptoms and methods of
management. Physicians must be familiar with the drug stability information in
the product technical manuals and must understand the dose relationship to
drug concentration and pump flow rate before prescribing pump infusion.
Implantation and ongoing system management must be performed by
individuals trained in the operation and handling of the infusion system. An
inflammatory mass that can result in serious neurological impairment, including
paralysis, may occur at the tip of the implanted catheter. Clinicians should
monitor patients on intraspinal therapy carefully for any new neurological signs
or symptoms, change in underlying symptoms, or need for rapid dose escalation.
Inform patients of the signs and symptoms of drug under- or overdose,
appropriate drug warnings and precautions regarding drug interactions,
potential side effects, and signs and symptoms that require medical attention,
including prodromal signs and symptoms of inflammatory mass. Failure to
recognize signs and symptoms and seek appropriate medical intervention can
result in serious injury or death. Instruct patients to notify their healthcare
professionals of the implanted pump before medical tests/procedures, to return
for refills at prescribed times, to carry their Medtronic device identification card,
to avoid manipulating the pump through the skin, to consult with their clinician
if the pump alarms and before traveling or engaging in activities that can stress
the infusion system or involve pressure or temperature changes. Strong sources
of electromagnetic interference (EMI), such as short wave (RF) diathermy and
MRI, can negatively interact with the pump and cause heating of the implanted
pump, system damage, or changes in pump operation or flow rate, that can
result in patient injury from tissue heating, additional surgical procedures, a
return of underlying symptoms, and/or a clinically significant or fatal drug
underdose or overdose. Avoid using shortwave (RF) diathermy within 30 cm of
the pump or catheter. Effects of other types of diathermy (microwave,
ultrasonic, etc.) on the pump are unknown. Drug infusion is suspended during
MRI; for patients who can not safely tolerate suspension, use alternative drug
delivery method during MRI. Patients receiving intrathecal baclofen therapy are
at higher risk for adverse events, as baclofen withdrawal can lead to a life
threatening condition if not treated promptly and effectively. Confirm pump
status before and after MRI. Reference product labeling for information on
sources of EMI, effects on patient and system, and steps to reduce risks from
EMI.
Precautions:
Monitor patients after device or catheter replacement for signs of
underdose/overdose. Infuse preservative-free (intraspinal) saline or, for vascular
applications, infuse heparinized solutions therapy at minimum flow rate if
therapy is discontinued for an extended period of time to avoid system damage.
EMI may interfere with programmer telemetry during pump programming
sessions. EMI from the SynchroMed programmer may interfere with other active
implanted devices (e.g., pacemaker, defibrillator, neurostimulator).
Adverse Events:
Include, but are not limited to, spinal/vascular procedure risks; infection;
bleeding; tissue damage, damage to the system or loss of, or change in, therapy
that may result in additional surgical procedures, a return of underlying
symptoms, and/or a clinically significant or fatal drug underdose or overdose,
due to end of device service life, failure of the catheter, pump or other system
component, pump inversion, technical/programming errors, or improper use,
including use of non-indicated formulations and/or not using drugs or system in
accordance with labeling; pocket seroma, hematoma, erosion, infection; postlumbar puncture (spinal headache); CSF leak and rare central nervous system
pressure-related problems; hygroma; radiculitis; arachnoiditis; spinal cord
bleeding/damage; meningitis; neurological impairment (including paralysis) due
to inflammatory mass; potential serious adverse effects from catheter fragments
in intrathecal space, including potential to compromise antibiotic effectiveness
for CSF infection; anesthesia complications; body rejection phenomena; local and
systemic drug toxicity and related side effects; potential serious adverse effects
from catheter placement in intravascular applications.
USA Rx Only
Rev 0311
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