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.
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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.
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.
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 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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