Medtronic Launches New Clinician Programmer for Deep Brain Stimulation Therapy
June 13 2018 - 7:00AM
FDA Approved, DBS
Clinician Programmer Optimizes the Programming Experience By
Addressing Day-to-Day Clinical Management Challenges
DUBLIN - June 13, 2018
- Medtronic plc (NYSE:MDT), the global leader in medical
technology, today announced that the U.S. Food and Drug
Administration (FDA) recently approved its state-of-the art Deep
Brain Stimulation (DBS) Clinician Programmer and
Activa(TM)Programming Application, which followed closely on the
recent achievement of CE Mark this past March. The
ActivaProgramming Application has been uniquely designed with the
input of over a hundred clinicians from around the world and is
managed on the Samsung Galaxy Tab S2 tablet interface. This modern,
familiar tool will enhance the clinical programming experience,
streamline workflows and provide actionable information to support
neurologists and neurosurgeons in their treatment of patients that
use the market leading, Medtronic Activa DBS system as therapy for
neurological diseases such as Parkinson's disease and
Dystonia1.
Globally, approximately 125,000 Medtronic
Activadevices are implanted, and this programmer will have an
immediate impact to the programming interactions that are a
critical part of post-implant care for thousands of patients. The
programmer will also enable the upgrade of Activa rechargeable
implantable neurostimulators service life to 15 years2, giving
patients an additional 6 years until their next device
replacement.
"After using the Medtronic Clinician Programmer
for the first time, I am impressed with the thoughtfulness put into
the user interface," said Dr. Mohammad Maarouf, associate
professor, head of the Department of Stereotaxy and Functional
Neurosurgery, Cologne Merheim Medical Center, University of
Witten/Herdecke, Germany. "Its intuitive, visual interface and
task-based workflow makes daily use easier, saving me time to focus
on what's most important-my patients."
The Medtronic DBS Clinician Programmer is also
approved for use with Medtronic Activa DBS systems that treat
medically refractory epilepsy, a therapy that will be launched
later this year in the U.S.
"This marks a new era of innovation from the only
partner with a 25-year DBS legacy, and paves the way to our vision
of the future of DBS with a fully integrated system from planning
to programming," said Mike Daly, vice president and general manager
of the Brain Modulation business, which is part of the Restorative
Therapies Group at Medtronic. "Additionally, this launch serves as
evidence of our dedication to the Medtronic Mission and our DBS
patients, with the extension of the device longevity of the
ActivaRC rechargeable neurostimulator. Now patients can benefit
from 6 extra years of therapy between surgeries, giving them even
more time to do the things they love."
The European launch of the Medtronic DBS Clinician
Programmer is underway, with the U.S. launch expected to take place
before the end of July 2018.
For more information on how Deep Brain Stimulation
(DBS) Programmer and Activa Programming Application work together,
visit MedtronicDBSTherapy's YouTube channel.
About Medtronic DBS
Therapy
DBS therapy uses a surgically implanted medical device, similar to
a cardiac pacemaker, to deliver electrical stimulation to precisely
targeted areas of the brain as adjunctive treatment for several
neurological disorders. Medtronic DBS systems are the first and
only approved for full-body MRI scans under specific conditions in
the United States. Since 1997, more than 150,000 Medtronic DBS
devices have been implanted worldwide for movement disorders and
other indications.
DBS therapy is currently approved in many
locations around the world, including the United States and Europe,
for the treatment of the disabling symptoms of essential tremor and
recent and longer-standing Parkinson's disease. Under Humanitarian
Device Exemption (HDE) approvals in the United States, the therapy
can also be used to treat chronic intractable primary dystonia and
severe, treatment-resistant obsessive-compulsive disorder.
The FDA-approved indication for epilepsy is as
follows: Bilateral anterior thalamic nucleus stimulation using the
Medtronic DBS System for Epilepsy is indicated as adjunctive
therapy for reducing the frequency of seizures in individuals 18
years of age or older diagnosed with epilepsy characterized by
partial-onset seizures, with or without secondary generalization,
that are refractory to three or more antiepileptic medications. The
Medtronic DBS System for Epilepsy has demonstrated safety and
effectiveness in patients who averaged six or more seizures per
month over the three most recent months (with no more than 30 days
between seizures) and has not been evaluated in patients with less
frequent seizures.
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.
All other brands, product names, company names,
trademarks and service marks are the properties of their respective
owners. All rights reserved.
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-
1 Dystonia is
approved under Humanitarian Device Exemption (HDE) in the
U.S.
2 Activa(TM) RC
devices eligible for the service life extension are those that have
been successfully interrogated with the Medtronic Tablet Clinician
Programmer prior to reaching End of Service (EOS).
Contacts:
David T. Young
Public Relations
+1-774-284-2746
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
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The issuer of this announcement warrants that they are solely
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information contained therein.
Source: Medtronic plc via Globenewswire
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