Electrical
Stimulation Blood Pressure Treatment Devices Market - Global Industry
Insights, Trends, Outlook, and Opportunity Analysis, 2018-2026
Electrical stimulation technology
has been in use for various applications such as pain management, neurological
and movement disorder management, musculoskeletal disorder management, and
metabolism & GIT management. However, products for the treatment of
resistance hypertension are under development. Despite significant advances in
the drug therapy, hypertension still remains a major clinical condition and a
key factor in the cardiovascular disease. Even changes in lifestyle habits such
as weight loss, exercise, reduced alcohol consumption, and dietary sodium
restriction are not sufficient. Thus new strategies and algorithms for the treatment
of hypertension are required.
Various alternative treatment
therapies are available such as renal denervation, the ROX coupler, and
baroreflex activation therapy. Renal denervation involves the catheter-based
ablation of both afferent nerves and efferent nerves. The technology looked
promising until 2014 when one of the major trials failed to meet the primary
end points. However, companies like Medtronic and Boston Scientific are
conducting new trials using modified renal denervation catheters. The ROX
coupler on the other hand is surgically implanted between a vein and artery in
the upper thigh, in a procedure called arteriovenous anastomosis.
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Baroreflex Activation Therapy
The baroreflex activation therapy
is a modified version of the earlier Rheos Baroreflex Activation Therapy
system. The concept behind electrical stimulation of baroreceptors or
baroreflex afferent nerves is that the stimulus is sensed by the brain as the
blood pressure increases. Then, baroreflex efferent structures are adjusted to
counteract the perceived blood pressure increase. The Barostim neo system from
CVRx is the most touted device in this category. The device has a CE Mark,
while the U.S. FDA has granted the technology an Expedited Access Pathway
designation. The device is under investigation for application in heart
failure.
This new electrical stimulation
implant could be a good alternative treatment option to drugs in blood pressure
patients. The fear of side effect can be overcome by using this implantable
device. Moreover, this device offers benefits such as non-destructive and
reversible treatment, 100% treatment compliance and meet every patient needs.
Market Scenario
Prevalence of hypertension is
highest among the low and middle income countries in Africa, Latin America, and
South-East Asian regions according to the World Health Organization (WHO).
Moreover, inadequate market penetration, large patient pool and aging population
are the major factors that will drive the demand for electrical stimulation
devices for the treatment of blood pressure in these regions. Moreover,
hypertension is also one of the major causes of morbidity and mortality in the
Unites States. In Canada, almost 20% of the hypertension patients have their
blood pressure above the normal level in spite of using an optimal combination
of at least three antihypertensive drugs. This statistics by the Canadian
Agency for Drugs and Technologies in Health (CADTH) is of the opinion that
collaboration between clinical specialties will be needed to appropriately
identify patients who may benefit from this procedure.
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The electrical stimulation
devices for blood pressure are under trials to establish their effectiveness.
Barostim neo system has received humanitarian device exemption for use in
patients with resistant hypertension from the U.S. FDA. However, it can only be
used in patients who had received implantation of the earlier generation,
bilateral Rheos Carotid Sinus Leads (now discontinued) during clinical trials.
Successful outcomes from the current trials will expedite the commercialization
of the device in next five years.
Key developments
Key players are involved in
various business strategies such as participating in international conferences
and medical fairs to market their products. For instance, in April 2018, BTL
Industries, Inc. participated at 79th China International Medical Equipment
Fair (CIMEF) in Shanghai, which was the largest fair of medical equipment and
services in Asia Pacific and second largest in the world.
Key players in the market are
involved in gaining approvals for devices from regulatory authorities, in order
to provide efficient devices in the market. For instance, in 2018, Medtronic
plc. announced the U.S. Food and Drugs Administration (FDA) approval to being
an investigational device exemption (IDE) pivotal trial to evaluate the
Symplicity Spyral (TM) renal denervation system in patients with high blood
pressure i.e. hypertension.
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