DUBLIN, June 7, 2021 /PRNewswire/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, today
announced the U.S. Food and Drug Administration (FDA) approval and
first U.S. implants of the SenSight™ Directional Lead System used
for Deep Brain Stimulation (DBS) therapy. SenSight is the
first-of-its-kind DBS directional lead that combines the benefits
of directionality with the power of sensing, allowing physicians to
deliver precise, patient-specific DBS therapy for the treatment of
some symptoms associated with movement disorders like Parkinson's
disease, dystonia and essential tremor, and medically refractory
epilepsy.
"Until now, sensing capability and directional leads have not
been available in the same DBS system, so we have had to choose one
technology or the other, based on the predicted needs of each
patient," said Kelly D. Foote, M.D.,
professor of neurosurgery at University of
Florida. "Now, by coupling this new directional lead with a
pulse generator capable of brain sensing, we are excited to be able
to offer our patients the synergistic benefits of both
technologies. Furthermore, the ability to continuously record brain
activity while affected patients go about their daily lives is a
powerful research tool that is rapidly improving our understanding
of these brain circuitry disorders that diminish the lives of so
many people."
DBS is a therapy in which a small pacemaker-like device sends
electrical signals through very thin wires, known as "leads," to a
targeted area in the brain related to symptoms of certain
neurological disorders. A few weeks after surgery, the neurologist
will wirelessly adjust the neurostimulator setting to best control
symptoms while minimizing potential side effects in a process known
as "programming."
For the SenSight directional lead system, Medtronic reimagined
how a lead system could be designed, with the patient,
neurosurgeon, and programming neurologist in mind. Deliberate
choices related to materials and design were made to enhance
comfort for patients, allow for more precise stimulation, and
streamline the surgical procedure—all while being able to capture
objective data for more efficient, informed programming.
SenSight is the first directional, sensing-enabled lead designed
to enhance the detection of local field potentials (LFPs), which
are brain signals that correlate with the severity of Parkinson's
disease symptoms and are 1 million times smaller than DBS
stimulation pulses1. When paired with the Percept™ PC
device, SenSight expands on BrainSense™ technology, enabling
clinicians to capture and record enhanced, directional LFP
information from the implanted lead. When physicians can detect
LFPs, they can correlate these brain signals with stimulation and
events capturing medication, symptoms, or side effects to deliver
personalized, data-driven therapy and adjust this therapy as
patient needs evolve.
"We are learning from studies across the globe as well as daily
patient care that knowing the absolute best location to implant a
lead can provide both very efficient and efficacious stimulation,"
said Leonardo Almeida, M.D.,
assistant professor of neurology at University
of Florida. "The more we continue to learn about signals
from different diseases and where they are located in relation to
where we usually target an implant, the more healthcare teams will
be able to refine targeting and accurately plan electrode
positioning for each specific patient."
SenSight directional lead systems were first implanted at the
University of Florida, by
multi-disciplinary teams in early June, and a full launch in the
U.S. will immediately follow today's announcement. The product also
recently received CE Mark and fully launched in Western Europe in March of 2021.
"We are excited to see the clinical benefits that the new
SenSight directional lead system will provide to patients and
physicians in the U.S.," said Mike
Daly, vice president and general manager of Brain Modulation
within the Neuromodulation business, which is part of the
Neuroscience Portfolio at Medtronic. "For over 25 years, Medtronic
has driven discoveries and advancements in DBS therapy and we look
forward to continuing to deliver meaningful innovation to the
movement disorder and epilepsy patient communities."
About Medtronic DBS Therapy
DBS 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.
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 175,000 Medtronic DBS devices
have been implanted worldwide for movement disorders and other
indications.
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 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.
1 Neumann WJ, Staub F, Horn A, et al. Deep brain
recordings using an implanted pulse generator in Parkinson's
disease. Neuromodulation. 2016;19(1):20-24.
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SOURCE Medtronic plc