Medtronic Receives CE Mark Approval for the Percept™ PC Neurostimulator DBS System with BrainSense™ Technology
10 January 2020 - 12:00AM
Medtronic plc (NYSE:MDT) today announced the CE
(Conformité Européenne) Mark for Percept™ PC
neurostimulator; it is the only Deep Brain Stimulation (DBS) system
to be launched in the European Union (EU) with
BrainSense™ technology that can sense and record brain signals
while delivering therapy to patients with neurologic disorders,
such as Parkinson’s disease. BrainSense technology enables
physicians to track patient-specific brain signals and correlate
these with patient-recorded events, such as symptoms or
side-effects associated with their disease or the medications to
treat it. This enables more personalized, data-driven
neurostimulation treatment. The Percept PC neurostimulator is
approved in the EU for the treatment of symptoms associated with
Parkinson’s disease (PD), essential tremor, primary dystonia as
well as epilepsy and obsessive-compulsive disorder (OCD). It is
currently under review by the U.S. Food and Drug Administration.
“DBS is proven to significantly improve motor
function in people with Parkinson’s disease compared to standard
medication alone – but with currently-available systems, physicians
need to make therapeutic decisions mostly based on clinical
assessments and patient-reported information,” said Professor
Andrea Kühn, head of Movement Disorders and Neuromodulation,
Charité University Hospital, Berlin. “Percept PC with BrainSense
technology is a game changer. Patients and their care teams will
have objective patient-specific brain signal data – including data
recorded outside the clinic in patients’ everyday lives. With this
technology, doctors could tailor therapy more precisely to the
individual needs of each patient based on data from neuronal
activity.”
In addition to BrainSense technology, the Percept
PC DBS system features several leading-edge innovations,
including:
- The only DBS system with MR conditional labeling that allows
for 3T and 1.5T full-body MRI scans, providing patients access to
cutting-edge medical imaging
- Improved battery longevity compared to Medtronic’s Activa™ PC
neurostimulator (when using similar settings and functionality) in
a smaller (reduced volume), ergonomic design for patient
comfort
- Low pulse width (duration of the pulse), providing expanded
stimulation options allowing for finer control over the neural
activation area
- Enhanced Patient Programmer leveraging a user-friendly,
custom-configured Samsung mobile device that allows patients to
manage their therapy easily
- Designed to easily facilitate expanded capabilities in the
future via software upgrades – to prepare for what’s next in
DBS
The Percept PC neurostimulator will be available
in Western Europe beginning January 15th and will launch in
additional regions based on local regulations.
“With the Percept PC device with
BrainSense technology, Medtronic is truly reinventing DBS
therapy, propelling it into a new frontier and empowering
clinicians with new options to bring the future of DBS to patients
today. Doctors can directly assess patients’ brain signals to
inform and provide customized treatment for each patient,”
said Mike Daly, vice president and general manager of the
Brain Modulation business, which is part of the Restorative
Therapies Group at Medtronic. “Patients are empowered to take
an active role in their therapy, and physicians can deliver
data-driven, personalized therapy that fits the needs of today’s
patients, now and in the future.”
About Medtronic DBS TherapyDBS therapy is
currently approved in many locations around the world, including
the United States and Europe, for the treatment of recent and
longer-standing Parkinson's disease, essential tremor, primary
dystonia, the disabling symptoms of epilepsy and
treatment-resistant obsessive-compulsive disorder.
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 was the
first in the United States to offer full-body MR Conditional DBS
systems for patients to have safe scans anywhere on the body under
certain conditions. Since 1987, more than 150,000 Medtronic DBS
devices have been implanted worldwide for movement disorders and
other indications.
About MedtronicMedtronic 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 90,000 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-
David T. YoungPublic Relations+1-774-284-2746
Ryan WeispfenningInvestor Relations+1-763-505-4626
- Percept™ PC Neurostimulator with BrainSense™ Technology
- Percept™ PC Neurostimulator Showing Stimulation
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