DUBLIN, June 10, 2021 /PRNewswire/ -- Medtronic plc
(NYSE: MDT), the global leader in medical technology, today
announced it has received U.S. Food and Drug Administration (FDA)
approval for Vanta™, a high performance recharge-free implantable
neurostimulator (INS) with a device life that can be optimized up
to 11 years. At comparable settings, the Vanta neurostimulator
offers nearly twice the device life than competitive primary cell
devices.1,2 It also utilizes Medtronic's proprietary
AdaptiveStim™ technology for personalized pain relief that adapts
to the patient's movement or body position using a built-in
accelerometer. AdaptiveStim technology goes beyond in-office
programming by automatically adjusting stimulation to maintain each
patient's optimal dose. The Vanta neurostimulator also provides
unmatched full-body MRI access with Medtronic SureScan™
technology.3 Approximately 82% of SCS-implanted
patients will need at least one MRI within five years of
implant.4
"Not every patient with chronic, intractable pain is an ideal
candidate for a rechargeable device, so the Vanta INS represents a
welcome addition to my portfolio of available treatment options,"
said Krishnan Chakravarthy, M.D.,
Ph.D., a San Diego-based
interventional pain management physician. "The extended
battery life, broad MRI compatibility and personalized relief
through AdaptiveStim technology allow for a more hassle-free
experience and greater freedom for my patients as we manage their
chronic pain."
Medtronic is continually innovating to advance spinal cord
stimulation therapy technologies that improve quality of life for
people with chronic pain. The Vanta neurostimulator represents a
10% increase in longevity compared to PrimeAdvanced™, Medtronic's
previous generation recharge-free device. It is also 20% smaller
than the PrimeAdvanced neurostimulator, with a more rounded,
ergonomic contouring to offer enhanced comfort. The Vanta system
provides access to Snapshot™ reporting, Medtronic's proprietary
data insights solution, offering clinicians objective reporting of
patient activity levels to empower objective health conversations.
Clinicians and their patients wishing to trial the Vanta
neurostimulator may also take advantage of CareGuidePro™, a mobile
application and web portal that serves as a virtual guide for
patients throughout their Medtronic spinal cord stimulation therapy
journey. CareGuidePro is currently in limited commercial release
with a full launch expected later this summer.
"We are committed to delivering innovative solutions that meets
the needs of every patient," said Charlie
Covert, vice president and general manager, Pain Therapies
within the Neuromodulation business, which is part of the
Neuroscience Portfolio at Medtronic. "For those who prefer or
require a recharge-free device, I believe the Vanta neurostimulator
offers the best hardware and features available today. We are
pleased to offer this solution, which is now part of the strongest
and broadest overall portfolio in this market."
Medtronic continues to focus on expanding access to its highly
effective DTM™ SCS therapy through pre-clinical and clinical work.
DTM SCS is currently available on the rechargeable Intellis™ SCS
platform, and the company expects to share more information about
its availability across the entire Medtronic spinal cord stimulator
portfolio later this summer.
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.
References
- Settings used from Abbott's Proclaim™ clinician manual. Nominal
settings 12 hours per day: 50-Hz frequency, 225-μs pulse width, and
5-mA amplitude at 500-ohms impedance. Compared to flagship model
3660.
- Settings from Boston Scientific's Alpha™ IFU. Programmed at
4.1mA, 280us, 40 Hz, 1 area, 730 Ohms, 2 contacts.
- Under specific conditions. Refer to product labeling for full
list of conditions.
- Desai MJ, Hargens LM, Breitenfeldt MD, et al. The rate of
magnetic resonance imaging in patients with spinal cord
stimulation. Spine. 2015;40(9):E531-537.
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SOURCE Medtronic plc