For Use with
SynchroMed(TM) II Intrathecal Drug Delivery System, the Control
WorkflowAims to Effectively Address Chronic Pain Without the Use of
Oral Opioids
DUBLIN - October 16, 2018 -
Medtronic plc (NYSE: MDT) today announced the U.S. launch of the
Control WorkflowSM, an
evidence-based approach for use with the SynchroMed(TM) II
intrathecal drug delivery system ("Medtronic pain pump") that helps
physicians wean patients off oral opioids and treat chronic
intractable pain. The Medtronic pain pump provides effective pain
relief at a fraction of the oral dose with fewer side effects and
has been shown to reduce or eliminate the use of oral opioids.
1-7 Prior to
the Control Workflow, a retrospective claims analysis (n=389) found
that 51 percent of chronic non-malignant pain patients eliminated
the use of oral opioids after one year on the pump.5
Given the current opioid epidemic and ongoing pain
management crisis, there is a need for solutions that effectively
address chronic pain. Many people use oral opioids to treat pain;
however, there is limited evidence on the effectiveness and
benefits of long-term oral opioid therapy.8 The Control
Workflow in combination with the Medtronic pain pump encourages
oral opioid elimination and can be used as an alternative to
long-term oral opioid therapy for appropriate patients.
"The Control Workflow assists me in identifying
appropriate patients who could benefit from targeted drug delivery
using the Medtronic pain pump, which is especially important with
the current opioid epidemic in the United States," said John A.
Hatheway, M.D., owner and provider, Northwest Pain Care, Spokane,
Wash. "The workflow is especially helpful for patients who may be
on high doses or cannot tolerate systemic opioids, or for those who
are not finding pain relief with systemic opioid therapy. By
placing the medication at the source of the pain, we can often
provide better pain relief with fewer side effects at a fraction of
the oral dose."
The Control Workflow includes oral opioid weaning
considerations that can be tailored to individual patients and
assists physicians in identifying patients likely to have positive
outcomes with the Medtronic pain pump. It supports oral opioid
tapering and drug holidays, allowing for treatment with the lowest
effective dose of intrathecal medication, which may improve pain
relief compared to a combination of oral and intrathecal
treatment.6 This
evidence-based approach was developed by clinicians and provides
comprehensive guidance on therapy initiation, catheter placement,
and dosing that could impact successful outcomes with the goal of
sustained pain relief and functional improvement.1,6
"There is a significant unmet need in chronic pain
and device-delivered options are underutilized for appropriate
patients, so we continue to innovate to maximize the value of
proven treatments," said Charlie Covert, vice president and general
manager of the Targeted Drug Delivery business, part of the
Restorative Therapies Group at Medtronic. "We rolled out the
Control Workflow to help simplify targeted drug delivery therapy,
support oral opioid weaning, and offer more patients an effective
alternative for pain relief. This is an important part of our
commitment to help address the opioid epidemic and pain management
crises. We will continue to partner with stakeholders to provide
clinical guidance that helps physicians understand when to consider
device-delivered treatments."
Many patients take progressively higher doses of
oral opioids without improvement in pain control, function, and
quality of life.8 It is
suspected the chronic use of oral opioids may treat end-of-dose
withdrawal rather than underlying pain, and patients frequently
report that their opioid doses merely "take the edge off" their
pain.9
Using the Control Workflowwith the Medtronic pain
pump gives some chronic pain patients another option that may prove
more effective than other therapies. These patients include those
taking high dose oral opioids with low efficacy or those who can't
tolerate oral opioids due to the side effects, such as
constipation, drowsiness, or changes in cognition.
Targeted Drug Delivery, an
Alternative to Oral Opioids
Oral opioid misuse is a significant issue, and it's more important
than ever for patients suffering from chronic pain to have access
to proven alternatives. Targeted drug delivery (TDD) may enable
systemic opioid reduction or elimination and may be considered as
an alternative to oral treatment for chronic pain.3
In a single-center, retrospective chart review (n=99) of patients
with chronic non-malignant pain who agreed to transition from
systemic opioids to TDD with the goal of eliminating systemic
opioids, 84 percent were able to eliminate opioid therapy within
one year.11
About Chronic Pain
Chronic pain, which lasts more than three to six months, is a
disabling condition that adversely affects wellbeing and can
interfere with working, sleeping, and participating in physical
activities, ultimately affecting quality of life. At least 100
million American adults - more than those affected by heart
disease, cancer, and diabetes combined - are affected by chronic
pain.10 It is
estimated that the cost to treat chronic pain in the U.S., as well
as related lost productivity, is as high as $635 billion
annually.12
About SynchroMedII Intrathecal
Drug Delivery System
The Medtronic SynchroMed II pump and catheter are implanted
under the skin and deliver medication into the intrathecal space,
enabling clinicians to prescribe reduced doses compared to
systemically delivered medications and tailor drug delivery to
patient needs. Patients with chronic, intractable pain who have not
had success with other treatment options or have experienced
intolerable side effects with oral medications are candidates for
the Medtronic pain pump.
About Medtronic Pain
Therapies
Medtronic has more than a 40-year history of developing innovative
medical devices that have been shown to alleviate pain in different
disease states and has a broad portfolio of device-delivered
therapies that are alternatives or adjuncts to oral
opioids.3 Medtronic
strives to be at the forefront of medical device innovation and to
develop high-quality pain therapies that reduce pain and improve
quality of life. While Medtronic pain therapies do not treat opioid
addiction, we are committed to leveraging our capabilities and
product portfolio in partnership with stakeholders - patients,
providers, payers, regulators, elected officials, patient advocacy
groups and employers - to address the unmet needs of pain patients
and to support efforts to prevent opioid misuse due to chronic
intractable pain.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services,
and solutions companies - alleviating pain, restoring health, and
extending life for millions of people around the world. Medtronic
employs more than 86,000 people worldwide, serving physicians,
hospitals, and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
References
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Hamza M, Doleys D, Wells M, et al. Prospective
study of 3-year follow-up of low-dose intrathecal opioids in the
management of chronic nonmalignant pain. Pain
Med. 2012;13(10): 1304-1313.
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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. Journal of clinical oncology: official journal of the
American Society of Clinical Oncology.
2002;20(19):4040-4049.
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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(1): 6-13.
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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(7):1010-1016.
-
Hatheway JA, Caraway D, David G, et al. Oral
opioid elimination after implantation of an intrathecal drug
delivery system significantly reduced health-care expenditures.
Neuromodulation : journal of the International Neuromodulation
Society. 2015;18(3):207-213.
-
Grider JS, Etscheidt MA, Harned ME, et al.
Trialing and maintenance dosing using a low-dose intrathecal opioid
method for chronic nonmalignant pain: a prospective 36-month study.
Neuromodulation : journal of the International
Neuromodulation Society. 2016;19(2):206-219.
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Onofrio BM, Yaksh TL. Long-term pain relief
produced by intrathecal morphine infusion in 53 patients. J Neurosurg. 1990;72(2):200-209.
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Chou R, Deyo RA, Devine B, et al. The effectiveness and risks of long-term opioid treatment
of chronic pain: evidence report/technology assessment No. 218.
AHRQ publication no. 14-E005- EF. Rockville, MD: Agency for
Healthcare Research and Quality; 2014.
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Managing Opioid Withdrawal. This Changed My
Practice - UBC CCP. https://thischangedmypractice.com/
managing-opioid-withdrawal/. VGH JPPN 3300, 910 W 10th Ave.
Vancouver, BC Canada V5Z 1M9.
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Institute of Medicine.
Relieving pain in America: a blueprint for transforming prevention,
care, education, and research. Washington DC, United States:
The National Academies Press; 2011.
-
Caraway D, Walker V, Becker L, Hinnenthal J.
Successful Discontinuation of Systemic Opioids After Implantation
of an Intrathecal Drug Delivery System. Neuromodulation: journal of
the International Neuromodulation Society.
2015;18(6):508-516.
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Darrell J. Gaskin, Patrick Richard. The Economic
Costs of Pain in the United States. The
Journal of Pain, 2012; 13 (8): 715
DOI: 10.1016/j.jpain.2012.03.009
Contacts:
Michelle Claypool
Public Relations
+1-763-526-9452
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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