YASTEST
Therapy Delivered
via the Medtronic SynchroMed(TM) II Infusion System
DUBLIN - January 11, 2018 -
Medtronic plc (NYSE:MDT) today announced the publication of results
from the 'Spasticity In Stroke-Randomised Study' (SISTERS)
trial in the Journal of Neurology,
Neurosurgery & Psychiatry (JNNP). These results demonstrate
the superiority of Medtronic ITB TherapySM with
Lioresal®Intrathecal (baclofen injection) delivered via the
SynchroMed(TM) II Infusion System compared to conventional medical
management (CMM) for the reduction of severe post-stroke spasticity
(PSS) in adults. The SynchroMed II Infusion System is the only
system approved in the United States for ITB Therapy.
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 activities
exhausting and difficult. More than 12 million people worldwide
suffer from spasticity.1 PSS impacts
up to 43 percent of patients in the first year after their
stroke2 and is
considered severe when it interferes with comfort, function or
caregiving, despite oral medications.3 Without
effective treatment, the excessive muscle tone can cause pain and
stiffness, deformity and reduced range of movement, significantly
reducing overall quality of life.4
SISTERS is the first randomized, controlled,
open-label, multicentre study to evaluate the efficacy and safety
of ITB Therapy versus CMM with oral antispastic medications for
treatment of PSS after six months' active treatment. Professor
Leopold Saltuari, M.D., from the Tirol Clinic in Hochzirl, Austria,
served as the coordinating investigator of the study, which
randomized 60 patients in Europe and the United States. The primary
outcome of the study was change in muscle tone and spastic
hypertonia as measured by the change in average Ashworth scale (AS)
score in the lower extremity (LE) of the affected body side from
baseline to month six.5
Results of the study show ITB demonstrated a
significant improvement over CMM in reducing muscle tone in the
affected lower and upper extremities. On the 5-point AS scale,
analysis showed mean AS score reduction for the affected lower
extremity, -0.99 [ITB] vs. -0.43 [CMM] and for the affected
upper extremity -.0.66 [ITB] vs. -0.17 [CMM]. Functional change was
evaluated using the Functional Improvement Measure (FIM). The ITB
group demonstrated an improvement in FIM total score from baseline
to month six (+2.68), while a worsening occurred in the CMM arm
(-2.58).5
More patients reported adverse events in the ITB
group (24/25 patients, 96 percent; 149 events) compared to CMM
(22/35, 63 percent; 77 events), although events were generally
consistent with the known safety profile of ITB Therapy. Around
half of the drug, device and procedure related adverse events
occurred during implant and titration phase. No patient
discontinued ITB Therapy due to treatment related adverse
events.5
"ITB Therapyis underused when it comes to treating
severe spasticity in post-stroke patients," said lead author and
study investigator Michael Creamer, D.O., of Central Florida Pain
Relief Centers in Orlando, Fla. "The study results demonstrate that
ITB Therapy is superior to oral medications in decreasing muscle
tone." Dr. Creamer will be presenting the study results at the
21st North
American Neuromodulation Society (NANS) Annual Meeting in Las Vegas
on Saturday, January 13, 2018.
Stroke affects people all around the world
regardless of gender, age or race. According to the World Health
Organization, 15 million people suffer stroke worldwide each year,
of these, 5 million are permanently disabled.6
"All over the world, PSS patients are suffering
from inadequately managed severe spasticity that can interfere with
their quality of life," said Charlie Covert, vice president and
general manager, Targeted Drug Delivery, Medtronic Pain Therapies.
"At Medtronic, we're committed to raising awareness of ITB Therapy
as an effective treatment for severe PSS and to ensure it is
available to the patients who need it most."
About ITB Therapy
ITB Therapy with Lioresal Intrathecal (baclofen injection) is
indicated for use in the management of severe spasticity resulting
from stroke, spinal cord injury, multiple sclerosis, cerebral palsy
and brain injury. Patients should first respond to a screening dose
of Lioresal Intrathecal prior to consideration for long term
infusion via an implantable pump. For spasticity of spinal cord
origin, ITB Therapy should be reserved for patients unresponsive to
oral baclofen therapy, or those who experience intolerable CNS side
effects at effective doses. Patients with spasticity due to
traumatic brain injury should wait at least one year after the
injury before consideration of long term ITB Therapy.
Abrupt discontinuation of intrathecal baclofen,
regardless of the cause, has resulted in sequelae that include high
fever, altered mental status, exaggerated rebound spasticity, and
muscle rigidity, that in rare cases has advanced to rhabdomyolysis,
multiple organ-system failure and death.
Prevention of abrupt discontinuation of
intrathecal baclofen requires careful attention to programming and
monitoring of the infusion system, refill scheduling and
procedures, and pump alarms. Patients and caregivers should be
advised of the importance of keeping scheduled refill visits and
should be educated on the early symptoms of baclofen withdrawal.
Special attention should be given to patients at apparent risk
(e.g. spinal cord injuries at T-6 or above, communication
difficulties, history of withdrawal symptoms from oral or
intrathecal baclofen).
Consult the technical manual of the implantable
infusion system for additional postimplant clinician and patient
information (See WARNINGS). |
For important safety information, including BOX
WARNING, refer to the Lioresal Intrathecal (baclofen injection)
prescribing information and the SynchroMed II Drug Infusion System
Brief Statement.
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 the lowest possible dose 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.7
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.
Lioresal® is a
registered trademark of Saol.
SynchroMed® is a
registered trademark of Medtronic.
-end-
Sources:
1. American Association of Neurological Surgeons.
Spasticity. Available at:
http://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity.
Accessed January 4, 2018.
2. Dvorak E, Ketchum N, McGuire J. The underutilization
of intrathecal baclofen in poststroke spasticity. Top Stroke Rehabil. 2011
May-Jun;18(3):195-202.
3. Saulino M, Ivanhoe C, McGuire J, et al. Best
practices for Intrathecal Baclofen Therapy: Patient Selection.
Neuromodulation. 2016 Aug;19(6):607-15.
4. Gillard PJ, Sucharew H, Kleindorfer D, et al. The
negative impact of spasticity on the health-related quality of life
of stroke survivors: a longitudinal cohort study. Health Qual Life
Outcomes. 2015;13:159.
5. Creamer M, Cloud G, Kossmehl P, et al. Intrathecal
baclofen therapy versus conventional medical management for severe
post-stroke spasticity: results from a multicentre, randomised,
controlled, open-label trial (SISTERS). J Neurol Neurosurg
Psychiatry. Published online Jan 2018. Doi:
10.1136/jnnp-2017-317021
6. World Health Organization (WHO): Global Burden of
Stroke. Available at:
http://www.who.int/cardiovascular_diseases/en/cvd_atlas_15_burden_stroke.pdf?ua=1.
Accessed December 15, 2017.
7. Medtronic Data on File. Accessed January 3, 2018.
Contacts:
David T. Young
Public Relations
+1-774-284-2746
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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