|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.
New Relic, Inc. has announced a set of new features across the New Relic Software Analytics Cloud that offer IT operations teams increased visibility, and the ability to diagnose and resolve performance problems quickly. The new features further IT operations teams’ ability to leverage data and analytics, as well as drive collaboration and a common, shared understanding between teams. Software teams are under pressure to resolve performance issues quickly and improve availability, as the comple...
Apr. 29, 2016 07:30 PM EDT Reads: 2,393
The proper isolation of resources is essential for multi-tenant environments. The traditional approach to isolate resources is, however, rather heavyweight. In his session at 18th Cloud Expo, Igor Drobiazko, co-founder of elastic.io, will draw upon their own experience with operating a Docker container-based infrastructure on a large scale and present a lightweight solution for resource isolation using microservices. He will also discuss the implementation of microservices in data and applicat...
Apr. 29, 2016 05:15 PM EDT Reads: 1,679
Join IBM June 8 at 18th Cloud Expo at the Javits Center in New York City, NY, and learn how to innovate like a startup and scale for the enterprise. You need to deliver quality applications faster and cheaper, attract and retain customers with an engaging experience across devices, and seamlessly integrate your enterprise systems. And you can't take 12 months to do it.
Apr. 29, 2016 04:30 PM EDT Reads: 1,756
See storage differently! Storage performance problems have only gotten worse and harder to solve as applications have become largely virtualized and moved to a cloud-based infrastructure. Storage performance in a virtualized environment is not just about IOPS, it is about how well that potential performance is guaranteed to individual VMs for these apps as the number of VMs keep going up real time. In his session at 18th Cloud Expo, Dhiraj Sehgal, in product and marketing at Tintri, will discu...
Apr. 29, 2016 04:30 PM EDT Reads: 601
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, will discuss how research has demonstrated the value of Machine Learning in delivering next generation analytics to im...
Apr. 29, 2016 03:45 PM EDT Reads: 1,592
This is not a small hotel event. It is also not a big vendor party where politicians and entertainers are more important than real content. This is Cloud Expo, the world's longest-running conference and exhibition focused on Cloud Computing and all that it entails. If you want serious presentations and valuable insight about Cloud Computing for three straight days, then register now for Cloud Expo.
Apr. 29, 2016 03:30 PM EDT Reads: 1,650
As you respond to increasing requests for new analytics, you need fast and flexible technology in your arsenal so that you can deploy the right workload to the right platform for the need at hand. Do you need self-service and fast time to value? Do you have data and application control and privacy needs, along with strict SLAs to meet? IBM dashDB™ is data warehouse technology powered by in-memory computing and in-database analytics that are designed for fast results, scalability and more.
Apr. 29, 2016 03:15 PM EDT Reads: 1,530
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Apr. 29, 2016 03:07 PM EDT Reads: 230
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Apr. 29, 2016 03:00 PM EDT Reads: 836
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
Apr. 29, 2016 02:45 PM EDT Reads: 835
IoT device adoption is growing at staggering rates, and with it comes opportunity for developers to meet consumer demand for an ever more connected world. Wireless communication is the key part of the encompassing components of any IoT device. Wireless connectivity enhances the device utility at the expense of ease of use and deployment challenges. Since connectivity is fundamental for IoT device development, engineers must understand how to overcome the hurdles inherent in incorporating multipl...
Apr. 29, 2016 02:30 PM EDT Reads: 1,397
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
Apr. 29, 2016 02:30 PM EDT Reads: 1,396
We’ve worked with dozens of early adopters across numerous industries and will debunk common misperceptions, which starts with understanding that many of the connected products we’ll use over the next 5 years are already products, they’re just not yet connected. With an IoT product, time-in-market provides much more essential feedback than ever before. Innovation comes from what you do with the data that the connected product provides in order to enhance the customer experience and optimize busi...
Apr. 29, 2016 02:00 PM EDT Reads: 826
The IETF draft standard for M2M certificates is a security solution specifically designed for the demanding needs of IoT/M2M applications. In his session at @ThingsExpo, Brian Romansky, VP of Strategic Technology at TrustPoint Innovation, will explain how M2M certificates can efficiently enable confidentiality, integrity, and authenticity on highly constrained devices.
Apr. 29, 2016 02:00 PM EDT Reads: 972
The paradigm has shifted. A Gartner survey shows that 43% of organizations are using or plan to implement the Internet of Things in 2016. However, not just a handful of companies are still using the old-style ad-hoc trial-and-error ways, unaware of the critical barriers, paint points, traps, and hidden roadblocks. How can you become a winner? In his session at @ThingsExpo, Tony Shan will present a methodical approach to guide the holistic adoption and enablement of IoT implementations. This ov...
Apr. 29, 2016 02:00 PM EDT Reads: 1,532