Rechargeable neurostimulator joins the
Medtronic Percept™ family – the first and only deep
brain stimulation system with sensing, directionality, and advanced
programming.
DUBLIN, Jan. 8, 2024
/PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in
healthcare technology, today announced the U.S. Food and Drug
Administration (FDA) approval of its Percept™ RC Deep Brain
Stimulation (DBS) system. The rechargeable neurostimulator is the
latest innovation in the Medtronic Percept™ family, which includes
the Percept™ PC neurostimulator, BrainSense™ technology†, and
SenSight™ directional leads. The Percept™ family is the only
sensing-enabled DBS system on the market, allowing the physician to
personalize treatment for patients with movement disorders such as
Parkinson's disease, essential tremor, and dystonia* as well as
epilepsy. Over 11 million people in the U.S. are living with
movement disorders1-2 and approximately 3.4 million with
epilepsy3.
"Our DBS therapy with exclusive BrainSense™ technology can help
control debilitating tremors for people living with Parkinson's,
providing patients with the ability to physically engage in
everyday moments – something many of us unintentionally take for
granted," said Amaza Reitmeier, vice
president and general manager, Brain Modulation within the
Neuromodulation business, which is part of the Neuroscience
Portfolio at Medtronic. "We are transforming brain modulation
through sensing-enabled DBS and will continue to drive therapy
innovation with the goal of many more peoples' lives improved with
Medtronic DBS therapy."
DBS uses a surgically implanted medical device, similar to a
cardiac pacemaker. Medtronic Percept™ neurostimulators transmit
electrical signals via slender wires to specific brain targets
affected by debilitating neurological disorders like Parkinson's
disease.
Percept™ RC is the smallest and thinnest dual
channel‡ neurostimulator available for DBS. It is
equipped with BrainSense™ technology that captures and records
brain signals to provide insights that enable a healthcare provider
to adapt and personalize therapy to a patient's evolving needs.
Unlike other rechargeable devices, the Percept™ RC battery offers
at least 15 years of service life with consistent and fast recharge
performance. Medtronic patented battery technology has less battery
fade than other rechargeable devices for a more reliable,
long-lasting battery.§ Patients can experience
rapid recharging from 10% to 90% full charge in less than an
hour.Ω
"While more data are needed, the sensing capability of this
unique deep brain stimulation system allows me the potential to
tune stimulation delivery to brain activity, which may be a way to
personalize this therapy for Parkinson's disease in the future,"
said Casey H. Halpern, M.D.,
Neurosurgeon and deep brain stimulation expert.
Nearly 70 percent of all DBS-eligible patients are estimated to
require an MRI as part of their essential
care4. 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 specific
conditions††.
Percept™ offers greater freedom and scan access for patients
with 3T scans and best-in-class 1.5T MRI scan
labeling5-7. Medtronic has the only DBS system that
allows patients to have stimulation on in bipolar mode during an
MRI5-7.†† In addition, the Percept™
neurostimulators are engineered to allow for future software
updates designed for the Percept™ platform without a
neurostimulator device exchange.
†† Under specific conditions. Refer to product labeling for
full list of
conditions: https://manuals.medtronic.com/manuals/mri/region
"This new rechargeable neurostimulator technology provides me
with insights into my patients' symptoms and can capture data even
when they're outside of the clinic," said Eleni Okeanis Vaou, M.D.,
FAAN, associate professor of neurology. "Now I have a rechargeable
DBS therapy option with sensing technology allowing me to track a
patient's response to DBS and medications. I use this data to
inform how to personalize and optimize patient therapy."
Dr. Vaou is a deep brain stimulation expert with the
University of Texas Health Science
Center at San Antonio (UT Health
San Antonio) and is not affiliated with Medtronic. She and the
institution do not endorse products or services.
Since 1987, Medtronic has served over 180 thousand patients in
more than 70 countries with its life-changing DBS
therapy8. Percept™ RC is available immediately
throughout the U.S., as well as via CE Mark approval in
Europe and availability in
Japan.
For further information on the Percept™ neurostimulators with
exclusive BrainSense™ technology, visit our website here.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc,
headquartered in Dublin, Ireland, is the leading global
healthcare technology company that boldly attacks the most
challenging health problems facing humanity by searching out and
finding solutions. Our Mission — to alleviate pain, restore health,
and extend life — unites a global team of 95,000+ passionate people
across 150 countries. Our technologies and therapies treat 70
health conditions and include cardiac devices, surgical robotics,
insulin pumps, surgical tools, patient monitoring systems, and
more. Powered by our diverse knowledge, insatiable curiosity, and
desire to help all those who need it, we deliver innovative
technologies that transform the lives of two people every second,
every hour, every day. Expect more from us as we empower
insight-driven care, experiences that put people first, and better
outcomes for our world. In everything we do, we are engineering the
extraordinary. For more information on Medtronic (NYSE:MDT),
visit www.Medtronic.com and
follow @Medtronic LinkedIn.
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.
Medtronic DBS therapy is approved for five indications:
Parkinson's disease, essential tremor, dystonia*,
obsessive-compulsive disorder* (OCD), and epilepsy. Indications
vary by product. Refer to product labeling for details.
*Humanitarian device: The effectiveness of these devices
for the treatment of dystonia and obsessive-compulsive disorder has
not been demonstrated.
† The sensing feature of the Percept™ PC and Percept™ RC system
is intended for use in patients receiving DBS where chronically
recorded bioelectric data may provide useful, objective information
regarding patient clinical status. The majority of patients with
Parkinson's disease have an identifiable signal. Signal may not be
present or measurable in patients treated for essential tremor,
dystonia*, epilepsy or obsessive-compulsive disorder*.
*Humanitarian device: The effectiveness of these devices for
the treatment of dystonia or obsessive-compulsive disorder has not
been demonstrated.
‡ As compared to Boston Scientific Vercise Genus™* R16 and
Vercise Genus™* P16. MP92328632-05 REV-A. As compared to St Jude
Medical Infinity™* 5/7 IPG. ARTEN600150429 - B.
§The Boston Scientific Vercise Genus™* R16 has a variable 5–15
years of service life, depending on the stimulation settings and
conditions (Vercise™* Deep Brain Stimulation Systems Information
for Prescribers MP92366224-01 Rev G, accessed August 22, 2023).
Ω For implant depths of up to 2.0 cm under normal
conditions.
References
1. Statistics on Parkinson's. Parkinson's Disease Foundation Web
site. https://www.parkinson.org/understanding-parkinsons/statistics.
Accessed 11/1/23
2. Louis ED, Ferreira JJ. How common is the most common
adult movement disorder? Update on the worldwide prevalence
of essential tremor. Mov Disord. 2010;25(5):534-541.
3. https://www.epilepsy.com Accessed 11/1/23
4. Falowski S, Safriel Y, Ryan MP, Hargens L. The rate of
magnetic resonance imaging in patients with deep brain
stimulation. Stereotact Funct Neurosurg. 2016;
94(3):147-153
5. ImageReady™ MRI Guidelines for Boston Scientific Deep Brain
Stimulation Systems — 92195369-01, accessed on 10/18/2023
6. MRI Procedure Information for Abbott Medical™* MR
Conditional Deep Brain Stimulation Systems —ARTEN600090482 A.
Accessed on October 18, 2023.
7. MRI guidelines for Medtronic deep brain stimulation systems
37601 37602 37603 37612 B35200 B35300 — M929535A_a_092
https://manuals.medtronic.com/manuals/mri/region
8. Medtronic data on file.
UC202407968 EN
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SOURCE Medtronic plc