BlueCross BlueShield of Tennessee Medical Policy Manual

Baroreflex Stimulation Devices


Baroreflex stimulation devices (e.g., Barostim neo® Legacy System, Barostim Therapy®) provide electrical stimulation of the baroreceptors in the carotid arteries using an implanted device. Baroreflex stimulation devices are being investigated as an alternative treatment for resistant hypertension and heart failure. Baroreceptors are pressure sensors contained within the walls of the carotid arteries.  They are part of the autonomic nervous system that regulates basic physiologic functions such as heart rate and blood pressure.  When these receptors are stretched, as occurs with increases in blood pressure, the baroreflex is activated resulting in various physiologic changes, including slowed heart rate and lower blood pressure.




In 2014, the Barostim neo® Legacy System (CVRx, Minneapolis, MN) received a humanitarian device exemption (HDE) from the FDA for use in individuals with treatment-resistant hypertension who received Rheos® Carotid Sinus leads as part of the Rheos pivotal trial and were considered responders in that trial. November 2015, CVRx received expedited access pathway (EAP) designation from FDA for Barostim Therapy® to treat heart failure.


Bakris, G., Nadim, M., Haller, H., Lovett, E., Schafer, J., & Bisognano, J. (2012). Baroreflex activation therapy provides durable benefit in patients with resistant hypertension: results of long-term follow-up in the Rheos Pivotal Trial. Journal of the American Society of Hypertension, 6 (2), 152-158. Abstract retrieved December 30, 2016 from PubMed database.

Bisognano, J. D., Bakris, G., Nadim, M. K., Sanchez, L., Kroon, A. A., et al. (2011). Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: Results from the double-blind, randomized, placebo-controlled Rheos Pivotal trial. Journal of the American College of Cardiology, 58 (7), 765-773. (Level 2 evidence)

BlueCross BlueShield Association. Evidence Positioning System. (5:2018). Baroreflex stimulation devices (8.01.57). Retrieved October 19, 2018 from (11 articles and/or guidelines reviewed)

Chunbin, W., Fu, S., & Jing, H. (2018). Efficacy and safety of baroreflex activation therapy for treatment of resistant hypertension: a systematic review and meta-analysis. Clinical and Experimental Hypertension, 40 (6), 501-508. Abstract retrieved October 22, 2018 from PubMed database.

Hoppe, U. C., Brandt, M. C, Wachter, R., Beige, J., Rump, L. C., Kroon, A. A., et al. (2012). Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: Results from the Barostim neo trial. Journal of the American Society of Hypertension, 6 (4), 270-276. (Level 4 evidence)

National Institute for Health and Care Excellence. (2015, October). Implanting a baroreceptor stimulation device for resistant hypertension. Retrieved March 7, 2016 from

Ng, F., Saxena, M., Mahfoud, F., Pathak, A., & Lobo, M. (2016). Device-based therapy for hypertension. Current Hypersion Report, 18 (61). (Level 2 evidence)

U.S. Food and Drug Administration. (2013, December) Center for Devices and Radiologic Health. Humanitarian device exemption H130007 (Barostim neo® Legacy System). Retrieved October 23, 2017 from

Weaver, F., Abraham, W., Little, W., Butter, C., Ducharme, A., Halbach, M., et al. (2016. Surgical experience and long-term results of baroreflex activation therapy for heart failure with reduced ejection fraction. Seminars in Thoracic and Cardiovascular Surgery, 28 (2), 320-329. (Level 3 evidence)




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