|By PR Newswire||
|January 7, 2014 06:00 AM EST||
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 data3,4. 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.
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.
- 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
- 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.
- 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.
- 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
- Erbel R, et al. The Heinz Nixdorf Recall study. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2012; 55 (6-7):809-15.
- Mancia G, et al. 2013 ESH/ESC Guidelines for the management of arterial hypertension. European Heart Journal 2013 34 (28): 2159-2219
- Go A, Heart Disease and Stroke Statistics. American Heart Association – 2013 Update. Circulation 2013;127:e6-e245.
- Prospective Studies Collaboration. Lancet 2002;360:1903-1913.
- 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.
@DevOpsSummit has been named the ‘Top DevOps Influencer' by iTrend. iTrend processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @DevOpsSummit ranked as the number one ‘DevOps Influencer' followed by @CloudExpo at third, and @MicroservicesE at 24th.
Oct. 21, 2016 04:30 PM EDT Reads: 3,776
24Notion is full-service global creative digital marketing, technology and lifestyle agency that combines strategic ideas with customized tactical execution. With a broad understand of the art of traditional marketing, new media, communications and social influence, 24Notion uniquely understands how to connect your brand strategy with the right consumer. 24Notion ranked #12 on Corporate Social Responsibility - Book of List.
Oct. 21, 2016 04:15 PM EDT Reads: 1,462
Established in 1998, Calsoft is a leading software product engineering Services Company specializing in Storage, Networking, Virtualization and Cloud business verticals. Calsoft provides End-to-End Product Development, Quality Assurance Sustenance, Solution Engineering and Professional Services expertise to assist customers in achieving their product development and business goals. The company's deep domain knowledge of Storage, Virtualization, Networking and Cloud verticals helps in delivering ...
Oct. 21, 2016 04:15 PM EDT Reads: 904
In his session at @DevOpsSummit at 19th Cloud Expo, Robert Doyle, lead architect at eCube Systems, will examine the issues and need for an agile infrastructure and show the advantages of capturing developer knowledge in an exportable file for migration into production. He will introduce the use of NXTmonitor, a next-generation DevOps tool that captures application environments, dependencies and start/stop procedures in a portable configuration file with an easy-to-use GUI. In addition to captu...
Oct. 21, 2016 04:00 PM EDT Reads: 1,457
Most of us already know that adopting new cloud applications can boost a business’s productivity by enabling organizations to be more agile and ready to change course in our fast-moving and connected digital world. But the rapid adoption of cloud apps and services also brings with it profound security threats, including visibility and control challenges that aren’t present in traditional on-premises environments. At the same time, the cloud – because of its interconnected, flexible and adaptable...
Oct. 21, 2016 04:00 PM EDT Reads: 2,673
SYS-CON Events announced today that SoftNet Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. SoftNet Solutions specializes in Enterprise Solutions for Hadoop and Big Data. It offers customers the most open, robust, and value-conscious portfolio of solutions, services, and tools for the shortest route to success with Big Data. The unique differentiator is the ability to architect and...
Oct. 21, 2016 03:54 PM EDT
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining senso...
Oct. 21, 2016 03:31 PM EDT Reads: 102
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Oct. 21, 2016 03:15 PM EDT Reads: 259
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
Oct. 21, 2016 03:00 PM EDT Reads: 4,353
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the...
Oct. 21, 2016 03:00 PM EDT Reads: 11,144
In the next five to ten years, millions, if not billions of things will become smarter. This smartness goes beyond connected things in our homes like the fridge, thermostat and fancy lighting, and into heavily regulated industries including aerospace, pharmaceutical/medical devices and energy. “Smartness” will embed itself within individual products that are part of our daily lives. We will engage with smart products - learning from them, informing them, and communicating with them. Smart produc...
Oct. 21, 2016 02:30 PM EDT Reads: 1,399
As ridesharing competitors and enhanced services increase, notable changes are occurring in the transportation model. Despite the cost-effective means and flexibility of ridesharing, both drivers and users will need to be aware of the connected environment and how it will impact the ridesharing experience. In his session at @ThingsExpo, Timothy Evavold, Executive Director Automotive at Covisint, will discuss key challenges and solutions to powering a ride sharing and/or multimodal model in the a...
Oct. 21, 2016 02:15 PM EDT Reads: 1,428
In his keynote at 19th Cloud Expo, Sheng Liang, co-founder and CEO of Rancher Labs, will discuss the technological advances and new business opportunities created by the rapid adoption of containers. With the success of Amazon Web Services (AWS) and various open source technologies used to build private clouds, cloud computing has become an essential component of IT strategy. However, users continue to face challenges in implementing clouds, as older technologies evolve and newer ones like Docke...
Oct. 21, 2016 02:15 PM EDT Reads: 2,196
SYS-CON Events announced today that Embotics, the cloud automation company, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Embotics is the cloud automation company for IT organizations and service providers that need to improve provisioning or enable self-service capabilities. With a relentless focus on delivering a premier user experience and unmatched customer support, Embotics is the fas...
Oct. 21, 2016 02:00 PM EDT Reads: 632
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
Oct. 21, 2016 02:00 PM EDT Reads: 6,778