FDA Approves Innovative Clinician Programmer for the Medtronic SynchroMed II Intrathecal Drug Delivery System for Chronic Pai...
January 10 2018 - 7:00AM
YASTEST
SynchroMed(TM) II
for Chronic Pain Is an Alternative to Systemic Opioids for Many
Patients
DUBLIN - January 10, 2018 -
Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug
Administration (FDA) approval of a new clinician programmer for use
with the SynchroMed(TM)II Intrathecal Drug Delivery system, an
implantable pump that provides targeted drug delivery for chronic
pain and severe spasticity. The SynchroMed II pump delivers
medication directly to the fluid around the spinal cord, which
provides relief at lower doses compared to oral medications in
appropriate patients with chronic pain1 or severe
spasticity.2 The new
SynchroMedII clinician programmer was designed to simplify therapy
management by providing clinicians with visual tools and intuitive
workflows and will soon be available in the U.S.
"With the ongoing opioid crisis, the ability
to reduce the use of systemic opioids and effectively manage my
patients' pain with the SynchroMed II pump system is more important
than ever," said Joshua Wellington, M.D., Indiana University
Health. "The new SynchroMed II clinician programmer helps simplify
therapy management, enabling me to focus on providing my patients
with pain relief through intrathecal delivery of
medications so that systemic opioids are reduced or
eliminated entirely."
The SynchroMed II clinician programmer is an
application that runs on a tablet that includes a vibrant screen
display and simple, guided workflows. The programmer features
visual enhancements such as side-by-side comparison of therapy
changes and flex dosing graphics. The clinician programmer
communicates wirelessly to the SynchroMed II pump and
auto-calculations help ensure accuracy and improve programming
confidence. Medtronic also recently secured FDA approval and
implemented four design changes to improve the design and
performance of the SynchroMed II Pump.
"Our new clinician programmer follows a series of
recent SynchroMed II Pump design changes and was developed with
patient safety in mind; our goal was to make it intuitive and
simple for clinicians to confidently tailor treatments to best meet
patients' needs," said Charlie Covert, vice president and general
manager, Targeted Drug Delivery, Medtronic Pain Therapies. "The
ability to assist with decreasing the need for systemic opioids is
critical, and Medtronic is committed to improving the lives of
patients with chronic pain and severe spasticity through continuous
innovation and therapy advancements."
Targeted Drug Delivery, An
Alternative to Oral Opioids
Systemic opioid abuse is a significant issue. Targeted drug
delivery will help allow for systemic opioid reduction or
elimination and may be considered as an alternative to oral
treatment for chronic pain.3 Intrathecal
drug delivery has been demonstrated to provide long-term pain
reduction.1
About Chronic Pain and Severe
Spasticity
Chronic pain, which lasts more than three to six months, is a
disabling condition that adversely affects wellbeing and can
interfere with working, sleeping, participating in physical
activities and enjoying life. At least 100 million American adults
- more than the total affected by heart disease, cancer, and
diabetes combined - are affected by chronic pain.4 People
suffering from severe spasticity have tight, stiff muscles that
make it difficult to move or control their arms, legs, or body,
which can make everyday life exhausting and difficult.
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 or severe
spasticity who have not had success with other treatment options or
have experienced intolerable side effects with oral medications are
candidates for SynchroMedII. The system is also full-body MRI
conditional under conditions specified in the product labeling.
More than 375,000 patients worldwide have received therapy from
Medtronic drug infusion systems since they were introduced over 30
years ago.
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 84,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 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
-
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.
-
Ertzgaard P, Campo C, Calabrese A. Efficacy and
safety of oral baclofen in the management of spasticity: A
rationale for intrathecal baclofen. J Rehabil
Med 2017;49(3):193-203.
-
Hatheway JA, et al. Systemic opioid elimination
after implantation of an intrathecal drug delivery system
significantly reduced health0care expenditures. Neuromodulation. 2015;18(3):207-213.
-
Relieving Pain in America: A Blueprint for
Transforming Prevention, Care, Education, and Research; Consensus
Report, Institute of Medicine (IOM), The National Academies Press,
June 2011.
Contacts:
Justin Ihle
Public Relations
+1-763-526-0911
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions 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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