Barostim Therapy™ Projected to be Cost-Effective in Treating Resistant Hypertension

MINNEAPOLIS, Jan. 7, 2014 /PRNewswire/ -- CVRx, Inc., a privately held medical device company, today announced findings from a health-economic analysis published in the Journal of Hypertension that indicates Barostim Therapy is a cost-effective treatment option for patients with drug resistant hypertension.  Based on blood pressure reductions attained with Barostim therapy, the Markov model used for this analysis projected that Barostim is a cost-effective treatment for this group of patients, with an anticipated incremental cost-effectiveness ratio (ICER) of 7,797 EUR per quality adjusted life year (QALY) gained from a payer perspective in a European setting¹. This is significantly below the recognized European cost-effectiveness threshold of 35,000 EUR.

The Barostim System is a programmable, minimally invasive device that consists of an implantable pulse generator (IPG), a 2mm electrode, and an external programmer.  Barostim Therapy is designed to trigger the natural blood pressure regulation system by electrically activating the carotid baroreceptors.  Barostim neo™ is the second generation system that is commercially available in Europe.  The therapy is included in the joint European Society of Hypertension and European Society of Cardiology guidelines for the treatment of resistant hypertension published in June, 2013.  Barostim Therapy is also under evaluation in a pivotal clinical trial in the U.S. intended to achieve U.S. market approval.

The reduction in blood pressure with Barostim Therapy was based on the double-blinded, randomized clinical trial published in the Journal of the American College of Cardiology² and long term follow up data^3,4. The study analyzed the impact of Barostim Therapy on a cohort of drug resistant hypertension patients with a systolic blood pressure > 170mmHg. Patient characteristics were based on the actual patients treated with Barostim Therapy in the randomized Barostim trial, as well as patient data from a large German epidemiological study⁵.

The health economic model in this study uses risk equations and cost data from the published literature to project the economic and clinical impact of Barostim Therapy for patients with drug resistant hypertension.  The model in the study is a combination of a decision tree and a Markov model, and it uses established multivariate risk equations from the Framingham heart study and the SCORE project to enable a robust projection of the impact of Barostim Therapy on cardiovascular events and mortality.

The model shows that Barostim Therapy may substantially reduce debilitating and costly cardiovascular events such as stroke, end stage renal disease (ESRD), myocardial infarction (MI), coronary heart disease (CHD) and heart failure.  Over a lifetime, Barostim is estimated to reduce the rate of stroke by 35%, ESRD by 23%, MI by 19%, and heart failure by 12%. Barostim was estimated to provide 1.66 additional life years and 2.17 additional quality-adjusted life years when compared with optimal medical management.

"This study provides an important perspective on the value of lowering the blood pressure for this group of drug resistant patients, clinically as well as from a health economic standpoint," said Joachim Beige, M.D, PhD, study co-author, Head KfH Renal Unit / Department of Nephrology, Hospital St. Georg, Leipzig, Germany.  "Moreover the estimated reductions in end-stage events such as stroke and end stage renal disease are substantial. This illustrates the impact which the blood pressure reduction of Barostim Therapy can have."

About Barostim neo
Barostim neo is a second generation device that uses CVRx-patented technology that is designed to trigger the body's own natural blood flow regulation system to treat hypertension and heart failure. The device received CE Mark approval in Europe in 2011.  The system works by electrically activating the baroreceptors, the body's natural blood pressure sensors that regulate cardiovascular function. These baroreceptors are located on the carotid artery. When activated by Barostim neo, signals are sent through neural pathways to the brain, which responds by telling the:

• Arteries to relax, making it easier for blood to flow through the body and reducing cardiac exertion;
• Heart to slow down, allowing more time for the organ to fill with blood; and
• Kidneys to reduce fluid in the body, lowering both excessive blood pressure and workload on the heart.

This unique, patented technology has the potential to improve quality of life and reduce health risks associated with hypertension and heart failure, including heart and kidney disease, stroke and death. Other key potential benefits of Barostim neo include the following:

• Can be adjusted to meet each patient's individual therapy needs, making it the only personalized medical device therapy for the treatment of hypertension with CE marking;
• Is a reversible treatment; and
• Provides 100% compliance to treatment, by automatically activating the baroreflex.

About Hypertension
In Europe, the prevalence of hypertension is estimated to be between 30-45% of the general population.⁶  In the United States, hypertension affects 77.9 million people.⁷ Worldwide, hypertension is estimated to cause one in every eight deaths.⁷ It is a major risk factor for cardiovascular disease, morbidity and mortality. Twenty-five percent of people with hypertension cannot adequately control their hypertension with medications and lifestyle modifications.^8,9 It is a disease that needs new treatment solutions.

About CVRx, Inc.
CVRx, Inc. is a privately held company founded in 2001 and headquartered in Minneapolis. The company has developed Barostim neo^™, a novel medical device system designed to treat hypertension and heart failure, two major unmet medical needs. Barostim neo received CE marking for the treatment of hypertension in Europe. Barostim Therapy for patients with drug resistant hypertension is included in the joint European Society of Hypertension and European Society of Cardiology hypertension treatment guidelines published in June, 2013. It is under clinical evaluation for the treatment of heart failure in Europe and the United States and under clinical evaluation for the treatment of hypertension in the United States. CVRx has treated more than 700 patients with its patented devices. For more information, visit CVRx.com.

1. Borisenko O, et al. Cost effectiveness of Barostim therapy for the treatment of resistant hypertension in European settings. Journal of Hypertension 2014 ; Published ahead of print.  www.jhypertension.com
2. Bisognano JD, et al. 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 2011; 58 (7):765-73.
3. Kroon AS, et al. Sustained blood pressure reduction by Baroreflex activation therapy with a chronically implanted system: 4-year data of Rheos Debut-HT study in patients with resistant hypertension. Journal of Hypertension 2010; 28:e441.
4. Bakris G, et al. 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) 2012 152-158
5. Erbel R, et al. The Heinz Nixdorf Recall study. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2012; 55 (6-7):809-15.
6. Mancia G, et al.  2013 ESH/ESC Guidelines for the management of arterial hypertension.  European Heart Journal 2013 34 (28): 2159-2219
7. Go A, Heart Disease and Stroke Statistics. American Heart Association – 2013 Update. Circulation 2013;127:e6-e245.
8. Prospective Studies Collaboration. Lancet 2002;360:1903-1913.
9. Chobanian AV. JNC 7: Complete Report. JAMA 2003;289:2560-2572.

CAUTION: Barostim neo is an investigational device and is limited by United States law to investigational use.

CVRx, Barostim Therapy, and Barostim neo are trademarks of CVRx, Inc. registered in the United States Trademark Office.

© CVRx, Inc. 2014. All rights reserved.

SOURCE CVRx, Inc.