- Breakthrough Device Designations are given by the U.S. FDA to
expedite the review of technologies that can improve the lives of
people with life-threatening or debilitating conditions
- Each year, 2.8 million Americans will fail multiple depression
therapies and be diagnosed with treatment-resistant depression
(TRD)
- With Breakthrough Device Designation, Abbott's deep brain
stimulation (DBS) System could become available as a new treatment
option sooner for people affected by TRD
ABBOTT
PARK, Ill., July 12,
2022 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced that the U.S. Food and Drug Administration (FDA) has
granted Breakthrough Device Designation to investigate the use of
its deep brain stimulation (DBS) system in treatment-resistant
depression (TRD), a form of major depressive disorder (MDD).
Breakthrough Device Designation expedites the review of innovative
technologies that can improve the lives of people with
life-threatening or irreversibly debilitating diseases or
conditions.
Abbott's DBS system is a personalized, adjustable therapy that
involves implanting thin wires – or leads – into targeted areas of
the brain. A pulse generator implanted under the skin in the chest
is connected to the leads and produces electrical impulses that can
modulate abnormal brain activity. While Abbott's DBS system has
traditionally been used to help control symptoms for people with
movement disorders, such as Parkinson's disease and essential
tremor, evidence suggests that implanting electrodes in the part of
the brain that regulates mood could help reduce symptoms of TRD.
Abbott is working with the FDA to develop a plan for evaluating the
device's safety and effectiveness for this purpose. One of
the added benefits of certain Abbott DBS systems is that they can
be used with NeuroSphere™ Virtual Clinic, a first-of-its-kind
connected care technology that allows people to communicate with
and receive care and therapy adjustments from their doctors
remotely and from the comfort of their own home*.
For patients who suffer from TRD, a condition that costs the
U.S. approximately $44 billion a year
in healthcare, unemployment and lost productivity1, deep
brain stimulation has the potential to offer meaningful improvement
of depressive symptoms. Currently, physicians have access to a
range of treatments for MDD, also called clinical depression,
including antidepressant medications and device therapies. Despite
this, up to a third of individuals diagnosed with MDD –
approximately 2.8 million Americans each year – do not respond even
after trying four different antidepressant regimen
approaches1,2 resulting in TRD or
difficult-to-treat depression. With each failed treatment, the
chance of experiencing a decrease in symptoms drops. By the fourth
failed treatment, as many as 83% of patients will
relapse.2
To qualify for a Breakthrough Device Designation, a device
technology must address an unmet need and show that it has the
potential to provide for more effective treatment of
life-threatening diseases or irreversibly debilitating conditions.
The goal of the program is to provide patients and clinicians with
timely access to these breakthrough treatments by accelerating
their development, assessment and review while maintaining
regulatory standards for pre-market approval. With
Breakthrough Device Designation, Abbott's DBS system could become
available as a new treatment option sooner for people affected by
TRD.
"Breakthrough product development always requires bold thinking
and collaboration, and Abbott is fully committed to the journey of
providing people with new therapeutic options for their
treatment-resistant depression," said Pedro Malha, vice president,
neuromodulation, Abbott.
Abbott DBS therapy for treatment resistant depression is limited
to investigational use only.
*Anywhere with a cellular or Wi-Fi connection and sufficiently
charged patient controller.
About Abbott
Abbott is a global healthcare leader that helps people live more
fully at all stages of life. Our portfolio of life-changing
technologies spans the spectrum of healthcare, with leading
businesses and products in diagnostics, medical devices,
nutritionals and branded generic medicines. Our 113,000 colleagues
serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter
@AbbottNews.
1 Zhdanava, M., Pilon, D., Ghelerter, I., Chow, W.,
Joshi, K., Lefebvre, P., & Sheehan, J. J. (2021). The
Prevalence and National Burden of Treatment-Resistant Depression
and Major Depressive Disorder in the
United States. The Journal of clinical psychiatry, 82(2),
20m13699.
2 Rush, A. J., Trivedi, M. H., Wisniewski, S. R.,
Nierenberg, A. A., Stewart, J. W., Warden, D., ... & Fava, M.
(2006). Acute and longer-term outcomes in depressed outpatients
requiring one or several treatment steps: a STAR* D report.
American Journal of Psychiatry, 163(11), 1905-1917.
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SOURCE Abbott