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.
The use of baroreflex stimulation implanted devices is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
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 https://www.evidencepositioningsystem.com. (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 www.nice.org.uk.
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 http://www.acessdata.gda.gov.
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)
ORIGINAL EFFECTIVE DATE: 8/9/2008
MOST RECENT REVIEW DATE: 12/13/2018
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.